FDA Adverse Event
Injury
Summary report: N
QUADRA ASSURA MP ICD
MDR report key: 15651542
·
Received October 21, 2022
Report
- Report Number
- 2017865-2022-39188
- Event Type
- Injury
- Date Received
- October 21, 2022
- Date of Event
- September 12, 2022
- Report Date
- October 21, 2022
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PLEASE NOTE THIS REPORT SUBMISSION IS NOT LATE. THE REPORT IS RESUBMITTED PER THE REQUEST FROM THE FDA, DUE TO MISSING 3RD ACKNOWLEDGEMENT. THIS IS CAUSED BY AN FDA ESG SERVER ISSUE FROM SEPTEMBER 21 ¿ 23, 2022. THIS ISSUE IS DOCUMENTED IN HELP TICKET (B)(4). THE INITIAL SUBMISSION ATTEMPT WAS PERFORMED ON SEPTEMBER 23, 2022.
Description of Event or Problem · 0
IT WAS REPORTED THAT POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE RECOMMENDED. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2241797 | QUADRA ASSURA MP ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CD3371-40QC | A000084747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |