FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 2812057
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15908
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING SYNCOPE AND WAS FOUND TO HAVE ATRIAL ARRHYTHMIAS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR [RV] LEAD HAD A HIGH SENSING INTEGRITY COUNT AND WAS T WAVE OVERSENSING. THE DEVICE WAS REPROGRAMMED AND THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE RV LEAD HAD LOSS OF CAPTURE AT FIVE VOLTS. THE RV LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO, INC. | 6943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| L| R | D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4568 IMPLANTABLE PACING LEAD |