FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3212939
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10094
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 17, 2013
- Report Date
- June 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- PHYSICIAN
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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCES LESS THAN 100 OHMS, LOSS OF CAPTURE, POOR/NO SENSING AND NOISE. THIS IMPACTED PACING THERAPY TO THE PATIENT, BUT THERE WAS NO ASYSTOLE GREATER THAN TWO SECONDS OBSERVED. IT WAS DETERMINED THERE WAS LIKELY AN INSULATION BREAK. DUE TO THE PERFORMANCE ISSUES WITH THE LEAD, SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313757 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization| L| R | 4087| 4088| K062| S601 |