FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 1073068
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02314
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
DURING FOLLOW-UP, A SENSING ANOMALY WAS OBSERVED. X-RAY SHOWED DEVICE MIGRATION AND LEAD DISLODGMENT. DURING THE PROCEDURE, TWIDDLER SYNDROME WAS CONFIRMED. THE DEVICE AND LEADS WERE REPOSITIONED AND REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT RF DR | IMPLANTIBLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |