FDA Adverse Event
Malfunction
Summary report: N
ENRHYTHM DR
MDR report key: 2053022
·
Received April 13, 2011
Report
- Report Number
- 6000144-2011-01576
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
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
THE PATIENT'S FAMILY REPORTED THAT THE PATIENT'S HEART RATE IS LOWER THAN NORMAL, AND THAT THE PATIENT'S BLOOD PRESSURE IS "VERY LOW". IT WAS REPORTED THAT THERE IS CONCERN THAT THE PACEMAKER IS "NOT WORKING." RECORDS INDICATE THAT THE PACEMAKER REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS 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 | 90 YR | Other | 3830 X2 IMPLANTABLE PACING LEAD |