BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 2192619 · Received August 3, 2011

    Report

    Report Number
    MW5021597
    Event Type
    Other
    Date Received
    August 3, 2011
    Date of Event
    August 3, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LWP
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PACEMAKER WAS IMPLANTED ON (B)(6) 2011. PT WAS SENT HOME. THE FOLLOWING DAY SHE FELT A TAPPING IN HER CHEST. THIS WAS FOLLOWED BY A PRICKLY SENSATION. EVENTUALLY SHE EXPERIENCED SEVERE CHEST PAIN. AN EKG AND XRAY WAS DONE. SHE WAS TOLD THAT THE PACEMAKER WAS PACING MORE THAN PREVIOUSLY ANTICIPATED. PAIN CONTINUED TO INTENSIFY. SHE HAD SLEEP DISTURBANCE, GASPING FOR BREATH, CRYING AND DECREASED RANGE OF MOTION. INFORMED THAT IT WAS INFLAMMATORY PERICARDITIS. SHE WAS GIVEN TORADOL FOR 5 DAYS. PT STARTED HAVING A LOW GRADE TEMPERATURE. IT WAS DISCOVERED ON (B)(6) 2011 THAT SHE HAD A VENTRICULAR PERFORATION CAUSED BY LEAD MIGRATION. LEAD WAS RELOCATED AND SHE STAYED OVERNIGHT IN THE ICU. SHE WAS TOLD THAT SHE LOST A SEVERE AMOUNT OF RBC'S. CURRENTLY, PAIN CONTINUES. SHE HAS BEEN UNABLE TO WORK AND IS ON RESTRICTED ACTIVITY. DR BELIEVES SHE HAS INFLAMMATORY PERICARDITIS FOR THE 2ND TIME. SHE STATED THAT HER DR BELIEVES THAT BECAUSE THE LEAD USED WAS NEW AND LOT IS NOT KNOWN ABOUT IT. IT IS LARGER AND THICKER THAN THE PREVIOUS LEADS THAT WERE USED. THE HELIX OF THE DEVICE IS SHAPER AND LONGER. THE LEAD MAY HAVE MIGRATED SLIGHTLY AGAIN. ELECTRICAL TESTING HAS BEEN DONE AND RESULTS ARE FINE. STABBING PAIN CONTINUES. PT IS CONCERNED ANOTHER PERFORATION IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC REVO SURE SCAN LWP MEDTRONIC 5086 MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR