BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE PULSE GENERATOR

    MDR report key: 2831939 · Received November 7, 2012

    Report

    Report Number
    MW5027580
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    September 12, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2012, A (B)(6) MALE PT DEVELOPED AN IMPLANTED PULSE GENERATOR (IPG) INFECTION PROBABLY RELATED TO A LEG INFECTION. IN (B)(6) 2011 THE PT, WITH HISTORY OF PARKINSON'S DISEASE DIAGNOSED IN 1999, HAD DEEP BRAIN STIMULATOR (DBS) SURGERY, INCLUDING BILATERAL LEADS IN THE SUBTHALAMIC NUCLEUS (STN), LEAD EXTENDERS, AND IMPLANTED PULSE GENERATOR (IPG) PLACEMENT IN THE LEFT CHEST WALL. HIS POST-OPERATIVE COURSE WAS UNCOMPLICATED, WITH FULL HEALING OF ALL INCISIONS DOCUMENTED AT HIS ONE MONTH POSTOPERATIVE VISIT. IN (B)(6) 2012, HE CUT HIS RIGHT LEG DOWN TO THE BONE WITH A HOUSEHOLD TOOL AND DEVELOPED SWELLING, PAIN AND REDNESS THAT PROGRESSED UP THE LEG, INDICATIVE OF CELLULITIS. AFTER ONE DAY HE WENT TO THE ED AND WAS PRESCRIBED UNSPECIFIED ANTIBIOTICS. UNFORTUNATELY, A WOUND CULTURE WAS NOT DONE AT THAT TIME. THE LEG INFECTION SUBSEQUENTLY HEALED. ABOUT THREE WEEKS LATER THE PT NOTED REDNESS AND SWELLING OVER HIS IPG, FOR WHICH HE TOOK ORAL ANTIBIOTICS UNTIL (B)(6) 2012. ON (B)(6) 2012, HE PRESENTED TO CLINIC. AT THAT TIME HE WAS NOTED TO HAVE ERYTHEMA AND SWELLING IN THE LEFT SIDE OF HIS CHEST. HIS IPG INFECTION WAS ASSESSED AS PRESUMED HEMATOGENOUS SEEDING FROM RECENT LEG TRAUMA. DEVICE REMOVAL WITHIN 24 HOURS WAS RECOMMENDED, BUT THE PT DID NOT CONSENT TO THIS AND WISHED TO RETURN THE FOLLOWING WEEK. AS A TEMPORIZING MEASURE, HE WAS PLACED ON ORAL CEPHALEXIN TO REDUCE THE CHANCE OF RAPID SPREAD OF THE INFECTION. ON (B)(6) 2012, THE IPG AND LEAD EXTENDERS WERE SURGICALLY REMOVED. TEMP AND WBC ON THAT DATE WERE WITHIN NORMAL LIMITS. A PICC LINE WAS PLACED AND THE PT WAS STARTED ON IV VANCOMYCIN. A WOUND CULTURE AND SENSITIVITY REVEALED (B)(6). A BRAIN MRI ON (B)(6) 2012, SHOWED NO EVIDENCE OF INTRACRANIAL INFECTION. THE PT HAD NO KNOWN RISK FACTORS FOR INFECTION, INCLUDING IMMUNOCOMPROMISE OR UNUSUAL EXPOSURE. AT THE TIME THE PT DEVELOPED CELLULITIS, HE WAS TAKING SINEMET 25/100, AVERAGE 1200 MG PER DAY; SINEMET 50/200 CR GHS; REQUIP XL 12 MG TID; AMANTADINE 100 MG TID; CLONAZEPAM 0.5 MG QHS; DULOXETINE 60 MG PER DAY; MIRTAZAPINE 45 MG GHS; AND ALPRAZOLAM AS NEEDED. REASON FOR USE: IDIOPATHIC PARKINSON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE PULSE GENERATOR ACTIVA PC MHY MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization