SYNCHROMED IIIRecalls & reported problems across all models
Medtronic, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,451
- Deaths reported
- 3
- Injuries reported
- 1,419
- Recalls
- 0
We found 4 models of SYNCHROMED III by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3,451 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2024 and Sep 30, 2026 — classified as 3 deaths, 1,419 injuries, 2,029 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (1,584 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SYNCHROMED III problems
Device problems
- Communication or Transmission Problem1,584
- Adverse Event Without Identified Device or Use Problem816
- Migration or Expulsion of Device314
- Application Program Problem284
- Insufficient Device Problem Information277
- Infusion or Flow Problem251
- Insufficient Flow or Under Infusion184
- Material Integrity Problem172
Patient problems
- No Clinical Signs, Symptoms or Conditions2,277
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available342
- Pain311
- Unspecified Infection299
- Insufficient Information200
- Cerebrospinal Fluid Leakage91
- Seroma85
- Headache69
SYNCHROMED III models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNCHROMED™ III 8667-20Pump, infusion, implanted, programmable1 death1,937 reports
- SYNCHROMED™ III 8667-40Pump, infusion, implanted, programmable2 deaths1,421 reports
- SYNCHROMED™ III 8667-20Pump, infusion, implanted, programmable52 reports
- SYNCHROMED™ III 8667-40Pump, infusion, implanted, programmable41 reports
Recent SYNCHROMED III adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952757 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: Cramp(s) /Muscle Spasm(s); High Blood Pressure/ Hypertension; Tachycardia
MAUDE report 50952752 ↗MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951535 ↗MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951370 ↗MalfunctionSep 30, 2026Communication or Transmission Problem; Environmental Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951096 ↗MalfunctionSep 30, 2026Application Program Problem; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950992 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950862 ↗MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950833 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950818 ↗MalfunctionSep 30, 2026Application Program Problem; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950672 ↗MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch
Information was received from a patient who was receiving Unknown Drug via an implantable pump for non-malignant pain indications for use. It was reported that their handset was lagging when connecting to the myPTM app. When asked for event date it 'seemed to start not very long, short weeks after' them getting the device. Agent walked the patient through clearing the data. Pt confirmed they were able to connect without lag. Troubleshooting steps taken on the call resolved the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950631 ↗MalfunctionSep 30, 2026Migration or Expulsion of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950562 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fluid Discharge
MAUDE report 50950549 ↗MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950511 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50949733 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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