FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 2122605
·
Received June 14, 2011
Report
- Report Number
- 6000144-2011-02217
- Event Type
- Injury
- Date Received
- June 14, 2011
- 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
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS 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 DEVICE WAS RETURNED AND ANALYZED. THE ELECTIVE REPLACEMENT INDICATOR (ERI) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS REMOVED AND ANOTHER WAS IMPLANTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 | 98 YR | Hospitalization| R | 5076 (X2) IMPLANTABLE PACING LEAD |