FDA Adverse Event
Injury
Summary report: N
PROTECTA XT CRT-D
MDR report key: 2791385
·
Received October 15, 2012
Report
- Report Number
- 6000094-2012-02242
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAS MIGRATED IN THE POCKET. IT WAS FURTHER REPORTED THE PATIENT COMPLAINED OF DEVICE DISCOMFORT AND NOTED THE SKIN WAS REDDENED AND HARD AROUND THE DEVICE AND DEVICE APPEARED CLOSE TO THE SKIN. A POCKET REVISION WAS PERFORMED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTECTA XT CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC S.A. | D354TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD| 4574 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD |