FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS DR, DF4 CONNECTOR
MDR report key: 3101145
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01923
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- February 27, 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 Location
- MS
- 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC WITH A DEVICE THAT WAS GETTING AN ERROR MESSAGE MULTIPLE TIMES WITH DIFFERENT PROGRAMMERS DURING AN ATTEMPTED INTERROGATION. A CORRUPTED EGM WAS SUSPECTED. AFTER CLEARING THE CORRUPTED EGM, INTERROGATION WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202896 | CURRENT PLUS DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |