FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS DR, SJ4 CONNECTOR
MDR report key: 1831117
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03588
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- July 7, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- SC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HV LEAD IMPEDANCES INVOLVING THE SVC COIL ELECTRODE HAVE STEADILY INCREASED SINCE IMPLANT. IT IS UNKNOWN IF THE CAUSE IS RELATED TO THE LEAD OR TO A CONNECTION ISSUE. DFT TESTING WAS SUCCESSFULLY COMPLETED WITH THE SVC COIL PROGRAMMED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT PLUS DR, SJ4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | 7120Q/52, (B)(4) |