FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS DR, DF-4 CONNECTOR
MDR report key: 1955229
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00476
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 8, 2010
- 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
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. THE DEVICE HAD A HIGH CURRENT DRAIN THAT DEPLETED THE BATTERY. ANALYSIS IDENTIFIED AN ANOMALOUS COMPONENT AS THE CAUSE FOR THE HIGH CURRENT AND PREMATURE DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED A NOTIFIER FOR DEVICE AT ERI. PATIENT HAD NO STORED VT/VF EPISODES SINCE IMPLANT. SESSION RECORDS WERE REVIEWED AND CONCLUDED THAT THE DEVICE RAPIDLY DEPLETED. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT PLUS DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |