FDA Adverse Event
Injury
Summary report: N
INTRINSIC
MDR report key: 2811957
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06197
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S041
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 THE PATIENT UNDERWENT 28 RADIATION TREATMENTS. THE DEVICE HAD AN ELECTRICAL RESET. THE DEVICE WAS REPROGRAMMED AND 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 | INTRINSIC | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |