FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 1073188
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02545
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 12, 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 Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ANOMALY OBSERVED IN THE FIELD WAS VERIFIED VIA REVIEW OF THE DEVICE DIAGNOSTICS. THE DEVICE'S HEADER WIRES WERE X-RAY INSPECTED; NO ANOMALY WAS SEEN. THE DEVICE WAS TESTED ON UTS (UNITY TEST SYSTEM) AND WAS FUNCTIONAL. THE SYSTEM DETECTED NO ANOMALY AND THE DEVICE MET ALL SPECIFICATIONS. THE IMPEDANCE ANOMALY COULD NOT BE REPRODUCED AND WAS UNDETERMINED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE HV LEAD IMPEDANCE WAS OUT OF RANGE. THE OVERALL VALUE WAS LESS THAN 10 OHMS. THE DEVICE AND LEAD WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 |