FDA Adverse Event
Malfunction
Summary report: N
REVEAL XT
MDR report key: 3991085
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14344
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Report Date
- May 8, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- DSI
- PMA / PMN Number
- K103764
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. THE IMPLANTABLE CARDIAC MONITOR WAS OBSERVED TO HAVE INTERMITTENT OVERSENSING OF BIGEMINY PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND UNDERSENSING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467564 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR |