FDA Adverse Event
Malfunction
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 2955521
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01445
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- December 12, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. CONCOMITANT PRODUCTS: 5568 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALERT TRIGGERED FOR HIGH RIGHT VENTRICULAR PACING IMPEDANCE AND ELEVATED SHORT INTERVAL COUNTS (SIC). 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 |
|---|---|---|---|---|---|---|---|
| 59610 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |