FDA Adverse Event
Death
Summary report: N
PROMOTE CRT-D
MDR report key: 4153509
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16391
- Event Type
- Death
- Date Received
- October 8, 2014
- Date of Event
- August 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
CORRECTION: NEW INFORMATION REPORTED STATED THAT THE CORRECT DATE FOR SECTION SHOULD BE UPDATED TO (B)(6) 2014.
Description of Event or Problem · 1
IT WAS REPORTED DURING THE IMPLANT PROCEDURE, THE PATIENTS CORONARY SINUS COULD NOT BE FOUND AND A COMPETITIVE EPICARDIAL LEAD WAS IMPLANTED. THE PATIENTS VITAL SIGNS DECREASED AND THE PATIENT EXPIRED THE NEXT DAY. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632049 | PROMOTE CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | 3107-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |