FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS DR, DF-4 CONNECTOR
MDR report key: 1955340
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00477
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- October 25, 2010
- 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 Location
- CA
- 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 THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A VIBRATORY ALERT FOR EXTENDED CHARGE TIME. IT WAS NOTED THAT THE PATIENT WANTS THE DEVICE EXPLANTED DUE TO DISCOMFORT FROM SHOCKS. IN NOVEMBER , IT WAS REQUESTED TO SCHEDULE THE PATIENT FOR REPEAT INTERROGATION. FURTHER INFORMATION COULD NOT BE OBTAINED AT THIS TIME.
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 | 67 YR |