FDA Adverse Event
Death
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1913395
·
Received December 3, 2010
Report
- Report Number
- 2649622-2010-12208
- Event Type
- Death
- Date Received
- December 3, 2010
- Date of Event
- November 21, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT DIED AND THE WIFE "THOUGHT THE DEVICE COULD HAVE BEEN THE CAUSE." SHE REPORTED THE CAUSE OF DEATH WAS HEART ATTACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death |