FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 3210498
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03288
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 26, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI MODE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER ON RESET. THE DEVICE WAS INSPECTED UNDER X-RAY AND A BROKEN CAN WIRE WAS OBSERVED. THE ROOT CAUSE OF THE FIELD EVENT OF BACKUP VVI MODE WAS THE BROKEN CAN WIRE.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A STRANGE FEELING IN THE ARMS WHILE RIDING A SNOW SCOOTER. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACK-UP VVI MODE. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310940 | CURRENT RF DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |