FDA Adverse Event
Malfunction
Summary report: N
CURRENT RF VR
MDR report key: 2984350
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00217
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- 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 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 IN (B)(6) 2012, THE PATIENT EXPERIENCED A VT/VF STORM. AN ALERT FOR EXTENDED CHARGE TIME AND A DECREASE IN BATTERY VOLTAGE WERE OBSERVED. A SLIGHT INCREASE IN HV LEAD IMPEDANCE OVER THE LAST FEW CHECK UPS WAS ALSO NOTED. DURING A RECENT FOLLOW-UP, THE CHARGE TIME WAS WITHIN NORMAL RANGE AND THE BATTERY VOLTAGE WAS LOW. FOLLOW-UP WILL CONTINUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87806 | CURRENT RF VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |