ENRHYTHM DR
Report
- Report Number
- 6000144-2011-00854
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- Z-1440-2010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 BATTERY TELEMETERED VALUE MEASURED 2.81 VOLTS AND THE 2.31 VOLTS LOADED. THE INCORRECT RECOMMENDED REPLACEMENT TIME BATTERY VOLTAGE MEASUREMENTS ARE THE RESULT OF HIGH INTERNAL BATTERY IMPEDANCE.
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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
IT WAS REPORTED THAT THE DEVICE ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED PREMATURELY, DUE TO HIGH BATTERY IMPEDANCE MEASUREMENTS. THE DEVICE WAS EXPLANTED AND 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 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| R | 4058M IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD| 4058M IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD |