FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 1990948
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00800
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- June 11, 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
- IA, US
- Reporter Occupation
- PHYSICIAN
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 DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD LOOSE ATRIAL SETSCREW. AFTER IMPLANTATION, THE RIGHT ATRIAL IMPEDENCE WAS HIGH AND THE THRESHOLD HAD RISEN. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE 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| R | (B)(4) IMPLANTABLE PACING LEAD |