FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 2692019
·
Received August 11, 2012
Report
- Report Number
- 6000144-2012-03904
- Event Type
- Injury
- Date Received
- August 11, 2012
- Date of Event
- March 20, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071641
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 PATIENT HAD PROLONGED PAIN AFTER IMPLANT OF THE IMPLANTABLE LOOP RECORDER (ILR). THE DEVICE IS STILL IN USE. THE PATIENT IS ENROLLED IN THE MANAGEMENT OF NEW-ONSET POSTOPERATIVE ATRIAL FIBRILLATION UTILIZING IMPLANTABLE LOOP RECORDER TECHNOLOGY TO OBSERVE RECURRENCE OF ATRIAL FIBRILLATION STUDY. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVEAL XT | IMPLANTABLE LOOP RECORDER | DSI | MEDTRONIC MED REL, INC. | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |