FDA Adverse Event
Malfunction
Summary report: N
ENRHYTHM DR
MDR report key: 2131019
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00885
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- Z-1440-2010
- 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 THE CLINICIAN WAS NOT SATISFIED WITH THE GENERAL DEVICE BEHAVIOR AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE CLINICIAN SUGGESTED ALLOWING THE USER TO SELECT THE PACING MODE WHEN DEVICE REACHES ERI RATHER THAN HAVING THE DEVICE ALWAYS DEFAULT TO VVI 65. NO SPECIFIC PATIENT WAS INVOLVED IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |