FDA Adverse Event
Injury
Summary report: N
CURRENT DR
MDR report key: 1073488
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02267
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- March 3, 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
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED HV LEAD IMPEDANCE ANOMALY COULD NOT BE REPRODUCED IN THE LABORATORY. NUMEROUS HVLIC MEASUREMENTS WERE PERFORMED OVER THE COURSE OF SEVERAL WEEKS. THE DEVICE PERFORMED NORMALLY AT ALL TIMES.
Description of Event or Problem · 1
IT WAS REPORTED THAT LOW HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED DURING A HV LEAD INTEGRITY CHECK. THE PATIENT NOTIFIER WAS NOT ACTIVATED. A FLUOROSCOPY SCAN RULED OUT ANY POSSIBLE LOOSE PIN CONNECTIONS. THE PHYSICAN ELECTED TO EXPLANT THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2107-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |