FDA Adverse Event
Malfunction
Summary report: N
ENRHYTHM DR
MDR report key: 1862929
·
Received October 9, 2010
Report
- Report Number
- 6000144-2010-05025
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Date of Event
- July 19, 2010
- Manufacturer
- MEDTRONIC MED REL, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DATA REVEALED "LOW TELEMETERED BATTERY VOLTAGE". ON 16-JUL-2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.59 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.97 V.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IN OFFICE BATTERY VOLTAGE MEASUREMENT WAS LOW AND AN INQUIRY WAS MADE IF THIS IS EARLY BATTERY DEPLETION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 | 89 YR | Other | 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD |