BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2953573 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01195
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 4068, IMPLANTABLE PACING LEAD, (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT A LEAD HAD A POLARITY SWITCH AND THE PATIENT BECAME SYMPTOMATIC WITH BEING OFF BALANCE AND FEELING LIKE GOING TO PASS OUT. THE PATIENT INDICATED THAT REPROGRAMMING HAD BEEN DONE, AND THE PATIENT HAD BEEN FINE BUT WAS AGAIN FEELING SIMILAR SYMPTOMS. FOLLOW UP WITH THE CLINIC FOUND THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS BOTH HAD A POLARITY SWITCH WHEN THE REPROGRAMMING WAS DONE BACK TO BIPOLAR. THEN APPROXIMATELY SEVEN WEEKS LATER THE PATIENT RETURNED WITH A TWITCHING SENSATION AND NOT FEELING WELL. THERE WAS A LEAD WARNING WITH LOW IMPEDANCE ON THE RA LEAD AND NOISE ON THE RV LEAD. THE RA AND RV LEADS WERE SET TO BIPOLAR AND REMAIN 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
    57545 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR