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Facility Graph → Medical Devices → Medtronic Neuromodulation
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Medical Devices FEI: FEI-ED320B06 🛡️ LEVEL 0 · PAPER REGISTRATION ONLY

Medtronic Neuromodulation

Registered Address: 7000 Central Ave Ne, Minneapolis, MN (United States)

For Brand Buyers: Medtronic Neuromodulation carries a A (80/100) rating due to documented FDA activity centered on cGMP documentation controls. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): openFDA Enforcement Reports · Resolved Name Aliases: Medtronic Neuromodulation
A
80/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 93th percentile among Medical Devices facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
A (80/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
77%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
5 Brands
~21 Downstream SKUs
🛡️ Run AI Mock Inspection on This Plant ⚖️ Compare Side-by-Side vs. Clean Co-Packers 📄 Request EIR via FOIA
Represent this facility? Claim profile or post 483 closeout response (Free)
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI FEI-ED320B06's FDA Record

5 Questions to Ask Medtronic Neuromodulation Before Signing a Manufacturing Contract

Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:

  1. Q1: Regarding Recall Z-0267-2027 (Class II on 2026-10-28), what line-clearance or preventive control changes were implemented to prevent recurrence?
  2. Q2: Since FDA databases show an electronic registration without a recorded physical FDA inspection, can you provide your most recent third-party SQF, UL, NSF, or ISO cGMP audit report?
  3. Q3: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
  4. Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI FEI-ED320B06?
  5. Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?

Cross-Database Regulatory & Inspection Timeline

Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.

FDA Enforcement Recall (Class II · Z-0267-2027) · 2026-10-28
View Recall Notice →
Product: InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Reason: Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.

Manufacturer Right-of-Reply & Free Match Correction

GUARDRAIL PROTECTED

To ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.

Dimension 3 · FDA 6-System Model

6-Subsystem cGMP Radar Breakdown

Sub-scores mapped across FDA's six core inspection subsystems.

Quality System (CAPA & OOS) 83/100
Materials & Incoming Identity 81/100
Production & Batch Records 82/100
Facilities, Sanitation & Pest 84/100
Laboratory & Stability Controls 81/100
Packaging & Allergen Labeling 85/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (80/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Recall (Class II) 2026-10-28 -12.0 pts Z-0267-2027 ↗