FDA Adverse Event
Malfunction
Summary report: N
CURRENT RF DR
MDR report key: 3791018
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10488
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Date of Event
- March 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
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 WHEN AN ASYMPTOMATIC PATIENT PRESENTED FOR ROUTINE DEVICE CHECK, INTERMITTENT VENTRICULAR UNDERSENSING WAS OBSERVED ON THE STORED EGMS. VARIABLE R-WAVES WAS SUSPECTED TO HAVE CAUSED THE ISSUE. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT PROGRAMMING CHANGES WERE MADE. PATIENT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268655 | CURRENT RF DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |