FDA Adverse Event
Injury
Summary report: N
THERA-I DR
MDR report key: 1925585
·
Received December 14, 2010
Report
- Report Number
- 2647346-2010-00874
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- September 30, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S37
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE CHANGE OUT IT OBSERVED THAT THE PARYLENE COATING HAD PEELED OFF OF THE DEVICE AND HAD BECOME INTERTWINED WITH TISSUES. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERA-I DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | 7960IB | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization| R | 5524M IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD |