FDA Adverse Event
Injury
Summary report: N
CURRENT RF VR
MDR report key: 1895909
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04235
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 13, 2010
- 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 Location
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ANOMALY OBSERVED IN THE FIELD WAS CONFIRMED IN THE LABORATORY. THE ANALYSIS INDICATED THE OUTPUT CIRCUITRY WAS WAS DAMAGED. AN INTERMITTENT CONNECTION WAS ALSO OBSERVED WITHIN THE HYBRID ASSEMBLY. THE CAUSE OF THE OUTPUT DAMAGE WAS NOT DETERMINED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR NOISE ON THE VENTRICULAR LEAD. A MESSAGE WAS DISPLAYED THAT THERE WAS POSSIBLE OUTPUT CIRCUIT DAMAGE. THE ICD AND LEAD WERE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT RF VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | 7021/65, (B)(4) |