FDA Adverse Event
Injury
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 3152409
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06826
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 11, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. CONCOMITANT MEDICAL PRODUCT: 1156T, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD T-WAVE OVERSENSING (TWOS) POST BIVENTRICULAR PACE. THE LEAD WAS PROGRAMMED TO IB (INTEGRATED BIPOLAR) SENSING AND REMAINS IN USE. IT WAS NOTED THAT THEY HAVE STRUGGLED IN THE PAST WITH PROGRAMMING THE LEAD TO AVOID TWOS POST PACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252810 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Required Intervention | D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB |