FDA Adverse Event
Death
Summary report: N
ANTHEM RF
MDR report key: 3961529
·
Received July 28, 2014
Report
- Report Number
- 2017865-2014-15759
- Event Type
- Death
- Date Received
- July 28, 2014
- Date of Event
- June 17, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z0430
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENTS CAUSE OF DEATH WAS SEPSIS, COLITIS AND GALLSTONES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437922 | ANTHEM RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM3210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Death |