FDA Adverse Event
Injury
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 3153570
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06106
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- January 30, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- 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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) WAS OBSERVED ON STORED EVENTS. TWOS WAS NOT SEEN REAL TIME. THE VENTRICULAR SENSITIVITY WAS DECREASED AND THE RIGHT VENTRICULAR (RV) LEAD 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 |
|---|---|---|---|---|---|---|---|
| 258753 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00036 YR | Required Intervention | D314DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |