ENRHYTHM DR
Report
- Report Number
- 6000144-2010-06290
- Event Type
- Injury
- Date Received
- December 14, 2010
- 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
- IL, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "LOW TELEMETERED BATTERY VOLTAGE". ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.81 V, WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.96 V. THIS DIFFERENCE IS RIGHT AT THE LIMIT OF THE EXPECTED RANGE (<150 MV).
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.
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 PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "LOW TELEMETERED BATTERY VOLTAGE". ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.81 V, WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.96 V. THIS DIFFERENCE IS RIGHT AT THE LIMIT OF THE EXPECTED RANGE (<150 MV). THE DEVICE WAS ALSO RETURNED AND ANALYZED. HIGH BATTERY IMPEDANCE CAUSED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TO TRIGGER.
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. EVALUATION SUMMARY: (B)(4) THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "LOW TELEMETERED BATTERY VOLTAGE". ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.81 V, WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.96 V. THIS DIFFERENCE IS RIGHT AT THE LIMIT OF THE EXPECTED RANGE (<150 MV).
IT WAS REPORTED THAT AT A DEVICE CHECK, THE DEVICE BATTERY VOLTAGE WAS 2.59 VOLTS, AND ONE MONTH LATER IT WAS 2.81 VOLTS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT AT A DEVICE CHECK, THE DEVICE BATTERY VOLTAGE WAS 2.59 VOLTS, AND ONE MONTH LATER IT WAS 2.81 VOLTS. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) PRIOR TO FIVE YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT AT A DEVICE CHECK, THE DEVICE BATTERY VOLTAGE WAS 2.59 VOLTS, AND ONE MONTH LATER IT WAS 2.81 VOLTS. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) PRIOR TO FIVE YEARS. 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 | 71 YR | Hospitalization| O| R | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD |