FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1853890
·
Received October 5, 2010
Report
- Report Number
- 2124215-2010-15182
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- December 31, 2004
- Report Date
- July 21, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE PRODUCT IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS PRODUCT DEVELOPED AN (B)(6) INFECTION AND THE ENTIRE PACING SYSTEM WAS EXPLANTED. IT WAS REPORTED THAT THE PATIENT LOST HIS LEG, GALLBLADDER, A KIDNEY AND HIS HEARING.
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 | 71 YR | Hospitalization| L| O| R| S | 1297| 4087| 4088 |