BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3051056 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04744
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 MEDICAL PRODUCT: ADDRL1, IMPLANTABLE PULSE GENERATOR, (B)(6) 2013. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT CHEST WALL STIMULATION FROM THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN PALPATED A MID-STERNAL AREA OF CHEST THAT WAS INTERMITTENTLY PULSING WITH RV PACING STIMULUS. REPOSITIONING TO SEVERAL RV SEPTUM LOCATIONS YIELDED SIMILAR CHEST WALL MUSCLE STIMULATION. FINAL RV FREE WALL POSITION YIELDED CHEST WALL STIMULATION AT HIGHER OUTPUTS (GREATER THAN 5.0 VOLTS), THOUGH NO STIMULATION AT LOWER OUTPUT AMPLITUDES. THIS WAS CONSIDERED TO BE ACCEPTABLE BY BOTH THE PATIENT AND PHYSICIAN. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153599 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD