FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK C
MDR report key: 3210264
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08174
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 2013
- Manufacturer
- HISTORICAL CPI ST. PAUL
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S DEVICE, THIS RIGHT VENTRICULAR (RV) LEAD WAS REMOVED FROM SERVICE. NOISE WAS OVERSENSED WHICH RESULTED IN GREATER THAN TWO SECONDS OF PACING INHIBITION/ASYSTOLE FOR THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309201 | ENDOTAK C | IMPLANTABLE LEAD | NVY | HISTORICAL CPI ST. PAUL | 0064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | 0180| 1857| 6937A| E161| MISMATCH| 0064 |