FDA Adverse Event
Malfunction
Summary report: N
FRONTIER II
MDR report key: 3920444
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14044
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- May 12, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NKE
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED INAPPROPRIATE MEASURED DATA. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014 DUE TO BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396031 | FRONTIER II | IMPLANTABLE PACEMAKER PULSE GENERATOR | NKE | ST. JUDE MEDICAL, INC., CRMD | 5596 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |