BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 3162375 · Received June 11, 2013

    Report

    Report Number
    2182208-2013-01841
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THE EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: EMERGENCY CARDIAC RESYNCHRONISATION IN A 4KG INFANT POST SURGICAL CLOSURE OF VENTRICULAR SEPTAL DEFECT. HEART LUNG CIRCUL. APRIL 1 2013;22(4):317-319. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 4965-35, IMPLANTABLE PACING LEAD - ATRIAL PRODUCT ID 4965-35, IMPLANTABLE PACING LEAD - VENTRICULAR.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE. THE PATIENT EXPERIENCED "FREQUENT RUNS OF SINUS TACHYCARDIA" AND THE POST-VENTRICULAR ATRIAL REFRACTORY PERIOD (LVARP) WAS REDUCED TO IMPROVE ATRIAL TRACKING. MEDICATIONS WERE ALSO USED, BUT IT BECAME APPARENT THAT THE TACHYCARDIA WAS DUE TO PACEMAKER SITE INFECTION/SEPSIS. THE DEVICE WAS EXTRACTED. THE PATIENT WAS TEMPORARILY PACED WITH A COURSE OF TWO WEEK OF ANTIBIOTICS. THE PATIENT THEN HAD A NEW PERMANENT PACEMAKER IMPLANTED. THE PATIENT'S VENTRICULAR FUNCTION CONTINUED TO IMPROVE AND AT TWO MONTHS POST DISCHARGE, THE LEFT VENTRICULAR (LV) EJECTION FRACTION (EF) WAS NORMAL. OF NOTE, AT SIX AND THEN 12 MONTHS POST PACEMAKER INSERTION, LV FUNCTION WAS "PRESERVED" AND A SMALL DOSE OF MEDICATION WAS CONTINUED TO MAINTAIN THE SINUS RATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE. THE PATIENT EXPERIENCED "FREQUENT RUNS OF SINUS TACHYCARDIA" AND THE POST-VENTRICULAR ATRIAL REFRACTORY PERIOD (LVARP) WAS REDUCED TO IMPROVE ATRIAL TRACKING. MEDICATIONS WERE ALSO USED, BUT IT BECAME APPARENT THAT THE TACHYCARDIA WAS DUE TO PACEMAKER SITE INFECTION/SEPSIS. THE DEVICE WAS EXTRACTED. THE PATIENT WAS TEMPORARILY PACED WITH A COURSE OF TWO WEEK OF ANTIBIOTICS. THE PATIENT THEN HAD A NEW PERMANENT PACEMAKER IMPLANTED. THE PATIENT'S VENTRICULAR FUNCTION CONTINUED TO IMPROVE AND AT TWO MONTHS POST DISCHARGE, THE LEFT VENTRICULAR (LV) EJECTION FRACTION (EF) WAS NORMAL. OF NOTE, AT SIX AND THEN 12 MONTHS POST PACEMAKER INSERTION, LV FUNCTION WAS "PRESERVED" AND A SMALL DOSE OF MEDICATION WAS CONTINUED TO MAINTAIN THE SINUS RATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM FOLLOW UP INDICATED THAT THE PATIENT IS NOW TWO YEARS OLD AND DOING "VERY WELL" AND IS DOING EVERYTHING AGE APPROPRIATE. IT WAS ALSO NOTED THAT THE INFECTION WAS NOTED TO BE CORRELATED WITH AN INFECTION ISSUE AT THE HOSPITAL AT THAT TIME. THERE WAS SIGNIFICANT ROAD CONSTRUCTION HAPPENING OUTSIDE THE HOSPITAL AND THE AIR CONDITIONING IN THE OPERATING ROOM WAS "NOT UP TO STANDARD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262954 VERSA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00002 MO Hospitalization| L| R