FDA Adverse Event
Injury
Summary report: N
QUADRA ASSURA MP ICD
MDR report key: 6202136
·
Received December 23, 2016
Report
- Report Number
- 2938836-2016-21800
- Event Type
- Injury
- Date Received
- December 23, 2016
- Date of Event
- October 31, 2016
- Report Date
- November 23, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
DURING FOLLOW-UP INTERROGATION REVEALED NON-SUSTAINED RV OVERSENSING DUE TO NOISE. THERAPY WAS INHIBITED AND THE PATIENT REPORTED DIZZINESS. THE DEVICE WAS REPROGRAMMED AND THE PATIENT IS IN GOOD CONDITION. THE PHYSICIAN BELIEVES THE NOISE WAS DUE ELECTROMAGNETIC INTERFERENCE (EMI) CAUSED BY AN EXTERNAL DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 852296 | QUADRA ASSURA MP ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC. | CD3371-40Q | 4542890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |