FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1952300
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-24629
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- March 11, 2003
- Report Date
- November 29, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS IMPLANTED AND THEREFORE WILL NOT BE RETURNED FOR ANALYSIS AT THIS TIME. IF THE LEAD IS RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE PATIENT'S FAMILY MEMBER THAT THE PATIENT WITH THIS PACING SYSTEM EXPERIENCED SYNCOPE. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE FOR THIS PACING SYSTEM. THE DEVICE REMAINED IMPLANTED FOR SEVEN YEARS AND WAS RECENTLY EXPLANTED, REPLACED AND RETURNED FOR NORMAL BATTERY DELETION. THE LEADS REMAIN IMPLANTED WITH THE NEW PACEMAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Hospitalization| R | 1298| 4063| 4087 |