FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS VR, DF-4 CONNECTOR
MDR report key: 3210684
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03347
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 8, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE BELOW THE EXPECTED LIMIT. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL ANOMALY WITHIN THE BATTERY WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP, PREMATURE ERI AND EOS WERE NOTED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309553 | CURRENT PLUS VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |