FDA Adverse Event
Death
Summary report: N
CAPSURE VDD-2
MDR report key: 1982883
·
Received February 9, 2011
Report
- Report Number
- 6000023-2011-00004
- Event Type
- Death
- Date Received
- February 9, 2011
- Date of Event
- April 24, 2010
- Manufacturer
- MEDTRONIC, B.V.
- Product Code
- DTB
- PMA / PMN Number
- P890003/S50
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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 DIED APPROXIMATELY EIGHT MONTHS FROM THE PACEMAKER REPLACEMENT IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, THE DEATH CERTIFICATE INDICATED THE CAUSE OF DEATH AS SEPSIS TWO DAYS), PNEUMONIA (FOUR DAYS), AND ASPIRATION (FOUR DAYS). THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE AND/OR LEAD RELATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY EIGHT MONTHS FROM THE PACEMAKER REPLACEMENT IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE VDD-2 | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, B.V. | 5038 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death| H| L| R |