FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR
MDR report key: 3880970
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-02315
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- January 17, 2013
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING F/U THE DEVICE WAS POST PACED T WAVE OVERSENSING ON THE NON SUSTAINED LEAD NOISE STORED EGM. THE PT DID NOT RECEIVE THERAPY. THE DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP WHEN POST-PACED T WAVE OVERSENSING. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24534 | FORTIFY ASSURA DR | IMPLANTABLE CARDIOVERTER DEFIBRILATOR | LWS | ST. JUDE MEDICAL INC., CRMD | CD2257-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |