FDA Adverse Event
Malfunction
Summary report: N
CURRENT RF VR
MDR report key: 2242460
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-05997
- Event Type
- Malfunction
- Date Received
- September 10, 2011
- Date of Event
- June 2, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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 DEVICE WAS MEASURING OUT OF RANGE IMPEDANCES FOR THE SVC VECTOR. THE IMPEDANCE WAS OUT OF RANGE FOR AT LEAST ONE YEAR. IT WAS NOTED THAT THE SVC SETSCREW MAY HAVE BACKED OUT. CHEST X-RAY AND REPROGRAMMING THE SHOCKING VECTOR TO RV TO CAN WAS RECOMMENDED. THE PHYSICIAN ELECTED TO LEAVE THE SYSTEM AS IS AND MONITOR THE PATIENT.
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 | 56 YR |