NA 6996TRecalls & reported problems
Medtronic, Inc. · ACCESSORY 6996T TOOL TUNNELING FINAL PK · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681490743761), received between Apr 26, 2024 and Apr 26, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE SUBCUTANEOUS RIGHT VENTRICULAR (RV) LEAD, THERE WERE HIGH DEFIBRILLATION THRESHOLD (DFT) TESTING WITH MULTIPLE SHOCKS AND SOME NEEDED EXTERNAL METHODS TO CONVERT THE RHYTHM. THE FIRST TWO DFT FAILED ON THE FIRST DEVICE CHECK AND WERE CONVERTED EXTERNALLY. THE MOBILE PROGRAMMER ABORT COMMAND WAS PRESSED AFTER THE ARRHYTHMIA WAS TERMINATED BUT PRIOR TO THE CHARGE DELIVERY BY THE DEVICE, AND IT DID NOT RESPOND TWICE, RESULTING IN THE PATIENT RECEIVING AN EXTRA SHOCK TWICE ON SEPARATE DFT ATTEMPTS EVEN AFTER PRESSING ABORT MULTIPLE TIMES. THE THIRD DFT WAS PERFORMED AFTER THE LEAD WAS REPOSITIONED. FOLLOWING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD A PNEUMOTHORAX. THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PNEUMOTHORAX WAS ALSO THOUGHT TO BE RELATED TO THE TUNNELING TOOL USED DURING PLACEMENT OF THE RV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pneumothorax
MAUDE report 19197588 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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