ProdigyRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 146
- Recalls
- 0
We found 3 models of Prodigy by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2018 and Jun 23, 2026 — classified as 146 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (46 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 Prodigy problems
Device problems
- Wireless Communication Problem46
- Improper or Incorrect Procedure or Method33
- Adverse Event Without Identified Device or Use Problem27
- Charging Problem8
- Communication or Transmission Problem7
- Insufficient Device Problem Information7
- Therapeutic or Diagnostic Output Failure7
- Use of Device Problem7
Patient problems
- Inadequate Pain Relief105
- Discomfort14
- Failure of Implant7
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient4
- Undesired Nerve Stimulation4
- Burning Sensation3
Prodigy models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prodigy™ 3799STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF142 reports
- Prodigy™ 3730STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF4 reports
- Prodigy™ 3856-RSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
Recent Prodigy adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Improper or Incorrect Procedure or Method; Wireless Communication Problem
IT WAS REPORTED THE IPG WAS UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS SITUATION.
Patient problems: Inadequate Pain Relief
MAUDE report 25597708 ↗InjuryApr 6, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT HAD NOT USED THE IPG FOR AN EXTENDED PERIOD OF TIME, RENDERING THE IPG INOPERABLE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24791508 ↗InjuryApr 3, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENTS IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2023 FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24779711 ↗InjuryDec 19, 2025No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless 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 WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 23853961 ↗InjuryDec 5, 2025Insufficient Device Problem Information; Wireless Communication Problem; Insufficient Device Problem Information; Wireless Communication Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT'S IPG WAS REPLACED DUE TO BEING INOPERABLE.
Patient problems: Inadequate Pain Relief; Insufficient Information
MAUDE report 23731739 ↗InjuryNov 25, 2025Improper or Incorrect Procedure or Method; Improper 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 23650439 ↗InjuryNov 14, 2025Wireless Communication Problem; Wireless 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 23560236 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SHOCKING AT THE IPG SITES, AND INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Implant Pain; Undesired Nerve Stimulation
MAUDE report 23491022 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Pocket Erosion
MAUDE report 23288773 ↗InjuryJul 24, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS CONFIRMED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 22586038 ↗InjuryJun 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THAT PATIENT UNDERWENT SURGICAL INTERVENTION AT UNKNOWN DATE FOR UNKNOWN REASON WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Insufficient Information
MAUDE report 22171622 ↗InjuryJun 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT¿S IPG WAS EXPLANTED AND REPLACED WITH A COMPETITOR¿S IPG FOR AN UNKNOWN REASON. THE DATE OF EXPLANT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22164686 ↗InjuryFeb 3, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT STOPPED CHARGING THE IPG DUE TO THE LEAD ISSUE (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00052 AND 1627487-2022-00053). AS SUCH, THE IPG BECAME INOPERABLE. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED POST OP.
Patient problems: Inadequate Pain Relief
MAUDE report 21289824 ↗InjuryJan 7, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT FOLLOWING ECG PROCEDURE, THE PATIENT WAS UNABLE CONNECT TO THE IPG TO TURN THERAPY ON. REPLACEMENT CHARGER/PROGRAMMER WAS UNABLE TO COMMUNICATE/RESOLVE THE ISSUE. AS SUCH, THE IPG IS INOPERABLE. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21093091 ↗InjuryDec 26, 2024Wireless Communication Problem; Wireless Communication Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.
Patient problems: Inadequate Pain Relief
MAUDE report 21019671 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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