FDA Adverse Event
Malfunction
Summary report: N
CURRENT ACCEL DR
MDR report key: 3880402
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03525
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- April 27, 2011
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED AN ERROR APPEARED ON INITIAL INTERROGATION. THE DEVICE WAS REBOOTED SEVERAL TIMES AND CHANGED THREE DIFFERENT MERLINS BUT ALL GAVE THE SAME MESSAGE. TECH SERVICES SAID THERE WAS A CORRUPTION IN THE EGM FILE THAT REQUIRED ERASURE OF ALL EGMS. THE DEVICE INTERROGATED NORMALLY AFTER CLEARING THE SEGMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24760 | CURRENT ACCEL DR | IMPLANTABLE CARDIOVERTER DIFIBRILLATOR, LWS | LWS | ST. JUDE MEDICAL, INC. CRMD | CD2215-36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |