FDA Adverse Event
Death
Summary report: N
PERMANENT PACEMAKER ELECTRODE
MDR report key: 6092447
·
Received November 10, 2016
Report
- Report Number
- 2938836-2016-14004
- Event Type
- Death
- Date Received
- November 10, 2016
- Date of Event
- October 13, 2016
- Report Date
- October 13, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). UPDATE RA LEAD MODEL/SN FROM UNKNOWN TO 1944/52, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED POST IMPLANT PROCEDURE. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT EXPIRED IN THE HOSPITAL; THE CAUSE DEATH WAS ASYSTOLE, BRADYCARDIA ARREST. THE PATIENT HAD ONE EPISODE OF CARDIAC ARREST 7 DAYS BEFORE DEATH AND 3 EPISODES OF SEVERE ASYSTOLE/BRADYCARDIA AFTER DEVICE IMPLANT. ACCORDING TO THE PHYSICIAN, PATIENT DEATH WAS NOT RELATED TO DEVICE OR PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743119 | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1944/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | (B)(4)| RA LEAD, UNK SERIAL# |