FDA Adverse Event
Malfunction
Summary report: N
CURRENT RF VR
MDR report key: 1830755
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03189
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- July 21, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 AFTER A DEVICE CHANGE-OUT FROM A MEDTRONIC DEVICE, THE HV LEAD IMPEDANCE ON THE MEDTRONIC LEAD WAS HIGH. INDUCTION ON THE NEW DEVICE WAS ADVISED BUT THE PHYSICIAN DECIDED NOT TO. THE HVLI TREND SHOWED THAT THE DEVICE WAS UNABLE TO MEASURE SVC IMPEDANCE DUE TO A DAMAGED COMPETITOR LEAD OR A CONNECTION PROBLEM.
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 | MEDTRONIC MODEL 6947 |