FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 2200599
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-03593
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- December 9, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071641
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS LISTING TIME OF BRADYCARDIA WHEN IT WAS NOT PICKING UP THE ELECTROCARDIOGRAM (EKG) COMPLEXES THAT FOLLOWED THE PREMATURE VENTRICULAR CONTRACTIONS (PVCS.) IT WAS ALSO REPORTED THAT WITH ACTIVITY THE PATIENT WOULD DEVELOP SYMPTOMATIC PVCS AND SINUS TACHYCARDIA. THE ILR WOULD CAPTURE NOISE AS ATRIAL FIBRILLATION/ATRIAL FLUTTER AND THE PATIENT WAS ALERTED ON NUMEROUS OCCASIONS TO DOWNLOAD DATA VIA THE MONITOR. THE ILR WAS REPROGRAMMED AND REMAINS IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVEAL XT | IMPLANTABLE LOOP RECORDER | DSI | MEDTRONIC MED REL, INC. | 9529 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |