FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 2050821
·
Received April 12, 2011
Report
- Report Number
- 6000144-2011-01488
- Event Type
- Injury
- Date Received
- April 12, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 A WARNING TRIGGERED STATING THAT THE DEVICE WAS PACING AT VVI 65, AND THAT AN MDT REP HAD TO BE CONTACTED. THE DEVICE WAS REPROGRAMMED, AND IS STILL 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 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD |