FDA Adverse Event
Injury
Summary report: N
SECURA VR
MDR report key: 1922354
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05934
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 10, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 DURING IMPLANT, THE DEVICE EXPERIENCED T-WAVE OVERSENSING (TWOS) AFTER VENTRICULAR PACES, AND THE DOCTOR WAS UNABLE TO PROGRAM THE DEVICE TO PREVENT THIS FROM OCCURRING. AFTER SEVERAL LEAD REPOSITIONING ATTEMPTS, A SATISFACTORY POSITION WAS OBTAINED. 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 | SECURA VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D224VRC | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R |