FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 2812479
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-05870
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- August 21, 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
- LA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.
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 MULTIPLE ASYSTOLE EPISODES WERE NOTED ON THE DEVICE FEW WEEKS POST IMPLANT POSSIBLY DUE TO UNDERSENSING AND ELECTRODE LOSS OF CONTACT. THE DEVICE SENSITIVITY WAS REPROGRAMMED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE ILR (IMPLANTABLE LOOP RECORDER) WAS REMOVED AND NOT REPLACED. 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 | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC MED REL, INC. | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| R |