FDA Adverse Event
Malfunction
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 2965008
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01899
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Report Date
- December 19, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 PRODUCT: 1888TC COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2011; D274TRK IMPLANTABLE PACEMAKER CARDIO/DEFIB (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALERT TRIGGERED FOR OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE. THEREFORE THE ALERT RANGE WAS INCRE ASED AND MONITORING CONTINUED. THE 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 |
|---|---|---|---|---|---|---|---|
| 68371 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Required Intervention | 4194 IMPLANTABLE PACING LEAD |