FDA Adverse Event
Injury
Summary report: N
INTRINSIC
MDR report key: 2053033
·
Received April 13, 2011
Report
- Report Number
- 6000094-2011-00518
- Event Type
- Injury
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S041
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- 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 PATIENT RECIEVED INAPPROPRIATE THERAPY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRINSIC | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC S.A. | 7288 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 4968 IMPLANTABLE PACING LEAD X2 |