FDA Adverse Event
Death
Summary report: N
KAPPA 900 DR
MDR report key: 1700047
·
Received May 27, 2010
Report
- Report Number
- 2647346-2010-00176
- Event Type
- Death
- Date Received
- May 27, 2010
- Date of Event
- July 11, 2009
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/014
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. EVALUATION SUMMARY (B) (4) BATTERY DEPLETION-NORMAL.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE MEDICAL EXAMINER THAT THE PATIENT DIED FROM ACUTE PULMONARY EMBOLISM AND THAT THE FAMILY IS NOW CONCERNED THE PACEMAKER MAY HAVE MALFUNCTIONED. THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 900 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR901 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death | (B) (4) IMPLANTABLE PACING LEAD| (B) (4) IMPLANTABLE PACING LEAD |