FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA MP ICD
MDR report key: 6141324
·
Received December 2, 2016
Report
- Report Number
- 2938836-2016-15232
- Event Type
- Malfunction
- Date Received
- December 2, 2016
- Report Date
- October 13, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PHYSICIAN FOUND POST-PASSED T-WAVE OVERSENSING DURING A FOLLOW-UP APPOINTMENT. THE PATIENT LOST THERAPY DUE TO THE OVERSENSING. THE PATIENT WAS IN GOOD CONDITION. TECHNICAL SUPPORT WAS CONTACTED AND PROGRAMMING RECOMMENDATIONS WERE RECOMMENDED FOR THE NEXT APPOINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792375 | QUADRA ASSURA MP ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD3371-40QC | 4869335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |