FDA Adverse Event
Malfunction
Summary report: N
FRONTIER II
MDR report key: 1896708
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05316
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 21, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NKE
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. WHEN PROGRAMMED TO LEFT VENTRICULAR BIPOLAR PACING, DIAPHRAGMATIC STIMULATION INCREASED. PROGRAMMING THE RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS TO UNIPOLAR DID NOT STOP THE DIAPHRAGMATIC STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FRONTIER II | IMPLANTABLE PACEMAKER PULSE GENERATOR | NKE | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5586 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |