FDA Adverse Event
Death
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1649168
·
Received April 2, 2010
Report
- Report Number
- 2649622-2010-01702
- Event Type
- Death
- Date Received
- April 2, 2010
- Date of Event
- February 11, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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. (B) (4) BATTERY DEPLETION-NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED FOR DEVICE AND LEAD EXPLANT DUE TO INFECTION/PACER ENDOCARDITIS. AFTER THE PROCEDURE, THE PHYSICIAN REPORTED "NO IMMEDIATE COMPLICATIONS WERE NOTED." LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED 4 DAYS AFTER THIS SURGERY. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH 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 | 86 YR | Death |