FDA Adverse Event
Malfunction
Summary report: N
REVEAL XT
MDR report key: 1991665
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00910
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- July 29, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071641
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NO ELECTROGRAM (ECG) RECORDING FOR THE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. 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 |
|---|---|---|---|---|---|---|---|
| 1 | REVEAL XT | IMPLANTABLE LOOP RECORDER | DSI | MEDTRONIC MED REL, INC. | 9529 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |