FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 1223694
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03558
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 4, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Additional Manufacturer Narrative · 1
THE ANOMALY OBSERVED IN THE FIELD WAS VERIFIED IN THE LABORATORY. THE HVLI MEASUREMENT FROM RV TO CAN WAS FOUND TO BE HIGH. THE DEVICE WAS PROGRAMMED TO DO SEVERAL SHOCKS AND DID NOT MEET SPECIFICATIONS. FURTHER ANALYSIS FOUND A SHORT WITHIN THE HYBRID SUBSTRATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT SEVERAL DAYS AFTER IMPLANT, HIGH SHOCK IMPEDANCE WAS OBSERVED. THE LEAD WAS REPLACED; HOWEVER, THE PROBLEM PERSISTED. AFTER THE DEVICE WAS CHANGED, ALL VALUES WERE NORMAL.
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 |