FDA Adverse Event
Malfunction
Summary report: N
FRONTIER II
MDR report key: 2905401
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00803
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- October 16, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NKE
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 DURING THE IMPLANT SURGERY OF THE PULSE GENERATOR, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION. THE PATIENT WAS SHOCKED. THE DEVICE EXHIBITED CAPTURE ANOMALIES. ON 10/17 THE PT EXPERIENCED VF/VT 8 TIMES AND HAD TO BE SHOCKED. THE PHYSICIAN CHANGED THE AV/ PV DELAY TO 350/325MS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12745 | FRONTIER II | IMPLANTABLE PACEMAKER PULSE GENERATOR | NKE | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5596 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |