FDA Adverse Event
Death
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1912709
·
Received December 2, 2010
Report
- Report Number
- 2649622-2010-12192
- Event Type
- Death
- Date Received
- December 2, 2010
- Date of Event
- October 8, 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
- WI, 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE PATIENT DRIVING IN TRUCK WITH HIS SPOUCE, HE CLUTCHED HIS HEART, VEERED OFF THE ROAD, AND HIT A TREE. THE PATIENT DIED WITH CAUSE OF DEATH REPORTED AS CAR ACCIDENT DUE TO ACUTE MYOCARDIAL INFARCTION DUE TO CORONARY ARTERY DISEASE. OTHER CONTRIBUTING FACTORS WERE NOTED TO BE MORBID OBESITY AND HEAD TRAUMA.
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 | 73 YR | Death |