FDA Adverse Event
Malfunction
Summary report: N
CURRENT RF DR
MDR report key: 3881172
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-02209
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- October 15, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. COMPANY REP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS SEEN TO BE UNDERSENSING VENTRICULAR EVENTS. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30273 | CURRENT RF DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL INC., CRMD | 2207-36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |