FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3212965
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10634
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 18, 2013
- Report Date
- June 18, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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 A REVISION PROCEDURE WAS PERFORMED AND ALL PRODUCTS WERE EXTRACTED AS A RESULT OF INFECTION. WHEN CLOSING THE POCKET, THE PATIENT WENT ASYSTOLIC AND CPR WAS PERFORMED. THE PATIENT DID WELL AND A TEMPORARY PACER WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312509 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | 0158| 4513| 4087| H219| 1823| N164 |