BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2210549 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06223
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS REPROGRAMMED WITH SUCCESSFUL CAPTURE OF SYMPTOM CONTROL.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO "BAD" IMPEDANCES. THE IMPEDANCE MEASUREMENTS WERE GOOD AT SURGERY. FOLLOWING THE PATIENT'S SURGICAL REVISION THE PATIENT STOOD UP AND BUMPED HIS HEAD ON A HANGING PLANT. THE IMPEDANCE MEASUREMENTS WERE LESS THAN 250 OHMS. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT AT THE REVISION SURGERY A NEW LEAD WAS PLACED IN THE EXACT SAME SPOT AS THE OLD LEAD. THE LEAD WAS FOUND TO BE BENT AT THE CONNECTION. THE LEAD WILL NOT BE RETURNED TO THE DEVICE MANUFACTURER. IN REGARDS TO THE PATIENT'S CURRENT IMPEDANCE ISSUES THE SURGEON ASSUMED THAT THE LEAD WAS DAMAGED BY THE PATIENT HITTING HIS HEAD DIRECTLY ON TOP OF THE STIMLOC. THE PATIENT HAD A DISTINCT RED BUMP FROM THE HIT. THE ASSUMPTION WAS ALSO MADE BECAUSE THERE WERE NORMAL IMPEDANCES POST IMPLANT AND ABNORMAL IMPEDANCES AT THE FOLLOW UP VISIT. THERE WERE NO PATIENT SYMPTOMS. THE STIMULATION WAS NOT ON PRIOR TO THE FOLLOW UP VISIT. NO INTERVENTIONS WERE REQUIRED OR PLANNED. THE PHYSICIAN WAS ABLE TO PROGRAM AROUND THE SHORTED ELECTRODES AND THE PATIENT WAS DOING GREAT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A BROKEN LEAD PRIOR TO THE (B)(6) 2011 REVISION. FOLLOWING THE REVISION THE PATIENT WAS TOLD THAT THE LEAD WAS BROKEN AGAIN, HOWEVER THE PATIENT STATED THAT IT WASN'T. IT WAS NOTED THAT THE PATIENT WAS LOOKING FOR A NEW MANAGING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL030074P| EXTENSION: MODEL 7489, LOT# NHU177978V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387S-40, LOT# V024501| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V475602