FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210228
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08397
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. IT WAS REPORTED THE LEAD WAS FRACTURED AND WAS ALSO EXHIBITING LOSS OF CAPTURE AT MAXIMUM OUTPUTS. SEVERAL EPISODES WERE STORED DUE TO NOISE. THE NOISE DID NOT RESULT IN ANY PACING INHIBITION AND NO SHOCKS WERE DELIVERED. THE DEVICE IMPLANTED WITH THIS LEAD WAS REPROGRAMMED TO MONITOR ONLY WITH THE RATE/SENSE SENSITIVITY REPROGRAMMED TO LEAST. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308948 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | 0184| T175 |