FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 3880988
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-02314
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- August 20, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
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.
Description of Event or Problem · 1
IT WAS REPORTED THT THE DEVICE WAS POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PT DID NOT RECEIVE THERAPY. IT WAS RECOMMENDED THAT THE PHYSICIAN REPROGRAM THE DEVICE. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25127 | QUADRA ASSURA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL INC., CRMD | CD3265-40Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |