FDA Adverse Event
Malfunction
Summary report: N
INTRINSIC
MDR report key: 1854956
·
Received October 5, 2010
Report
- Report Number
- 6000144-2010-04339
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- August 20, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S041
- Removal / Correction Number
- ASKU
- 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 DEVICE HAD AN ELECTRICAL RESET. IT WAS FURTHER REPORTED THAT THREE DAYS LATER THAT THE DEVICE WAS BEEPING AS A RESULT OF ANOTHER ELECTRICAL RESET. THE PATIENT HAD NOT HAD SURGERY OR ANY RADIATION TREATMENTS THAT MIGHT HAVE TRIGGERED THE RESET. THE DEVICE WAS RESET; PROGRAMMING AND CHARGE CAPACITOR WERE CHECKED AND WERE FINE. 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 | INTRINSIC | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7288 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other | 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD |