FDA Adverse Event
Death
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1970742
·
Received January 25, 2011
Report
- Report Number
- 2649622-2011-00109
- Event Type
- Death
- Date Received
- January 25, 2011
- 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
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A POCKET INFECTION AFTER IMPLANT WHICH PROGRESSED TO (B)(6). ANTIBIOTIC THERAPY WAS GIVEN AND THE PATIENT WAS TRANSFERRED TO A LARGER FACILITY FOR A SYSTEM EXPLANT. THE ENTIRE SYSTEM WAS EXPLANTED AND THE 5076 LEAD WAS IMPLANTED AS A TEMPORARY PACING LEAD. THREE DAYS POST EXPLANT OF SYSTEM AND IMPLANT OF TEMPORARY LEAD THE PATIENT EXPIRED. CAUSE OF DEATH AND ADDITIONAL INFORMATION ABOUT THE CIRCUMSTANCES SURROUNDING THE DEATH HAVE BEEN REQUESTED AND NOT YET 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 | 26 YR | Death| H| L| R | LEAD/STJ IMPLANTABLE PACING LEAD |