ProtégéRecalls & reported problems across all models
St. Jude Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,672
- Deaths reported
- 1
- Injuries reported
- 1,666
- Recalls
- 0
We found 2 models of Protégé by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,672 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Jul 31, 2026 — classified as 1 death, 1,666 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (502 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 Protégé problems
Device problems
- Improper or Incorrect Procedure or Method502
- Wireless Communication Problem462
- Adverse Event Without Identified Device or Use Problem210
- Use of Device Problem161
- Therapeutic or Diagnostic Output Failure124
- Insufficient Device Problem Information92
- Premature Discharge of Battery61
- No Device Output54
Patient problems
- Inadequate Pain Relief1,343
- No Consequences Or Impact To Patient74
- Failure of Implant65
- No Clinical Signs, Symptoms or Conditions58
- Implant Pain42
- Pain42
- Insufficient Information41
- Discomfort34
Protégé models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Protégé™ 3789STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death1,226 reports
- Protégé™ 3789STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF446 reports
Recent Protégé adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Improper or Incorrect Procedure or Method; Wireless Communication Problem
It was reported that the patient's IPG became unable to communicate with external devices. As a result, surgical intervention may be undertaken in the future.
Patient problems: Inadequate Pain Relief
MAUDE report 50105498 ↗InjuryJun 25, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25627005 ↗InjuryJun 11, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25470801 ↗InjuryJun 10, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25459388 ↗InjuryJun 8, 2026Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TOA DDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25437218 ↗InjuryMay 28, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25322004 ↗InjuryApr 27, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 24999075 ↗InjuryApr 7, 2026No Apparent Adverse Event
ADDITIONAL INFORMATION INDICATES THE IPG MEETS OR EXCEEDS 75% OF ITS EXPECTED LONGEVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808163 ↗InjuryApr 6, 2026Wireless Communication Problem
IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24794159 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 24714589 ↗InjuryFeb 27, 2026Wireless Communication Problem
IT WAS REPORTED PATIENT'S THORACIC LEAD HAS HIGH IMPEDANCES. PATIENT WAS UNABLE TO CHARGE THE IPG SINCE 2024. TO ADDRESS THE ISSUES, SURGICAL INTERVENTION MAY BE PENDING.
Patient problems: Inadequate Pain Relief
MAUDE report 24474871 ↗InjuryFeb 16, 2026Wireless Communication Problem
IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. IT IS UNKNOWN IF THE PATIENT STOPPED CHARGING THE DEVICE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: Inadequate Pain Relief
MAUDE report 24347451 ↗InjuryJan 27, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR IPG EXPLANTED ON AN UNKNOWN DATE TO HAVE PAIN PUMP IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24193687 ↗InjuryJan 14, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24071490 ↗InjuryJan 9, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE. DURING IPG REPLACEMENT THE PATIENTS LEAD HAD A HIGH IMPEDANCE. AS A RESULT, THE LEAD WAS ALSO REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24027712 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 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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