BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3241201 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12109
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V238061, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 8840, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERCUTANEOUS LEAD WAS IMPLANTED TWO WEEKS PRIOR. DURING THE STAGE II IMPLANT TO IMPLANT THE STIMULATOR THE IMPEDANCES READ C/0 1058 15UA, C/1 1704 AND 11UA, C/2 1040 15UA, C/3 >2000 AND <(><<)>7UA. 0/1 >2000 AND 10, 0/2 <(><<)>50 AND 269UA, 0/3 >2000 AND <(><<)>7UA, 1/2 >2000 10UA, 1/3 >2000, <(><<)>7UA, 2/3 >2000 <(><<)>7UA IMPEDANCES. NO INTERVENTION WAS PERFORMED. PATIENT WAS GOING TO BE PROGRAMMED IN THE OUTPATIENT CLINIC IN 2 -3 WEEKS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL WITH HIS ONE SIDE. THE 2ND SIDE HAD A BREAK IN THE SYSTEM. THERE WAS NO KNOWN INTERVENTION OR ATTEMPT TO OPTIMIZE THE SECOND SIDE SINCE THE PATIENT HAD SUBSTANTIAL ISSUES WITH THE HARDWARE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPEDANCE MEASUREMENTS WERE >4 ,000 OHMS ON SOME OR ALL UNIPOLAR PAIRS. IMPEDANCES READ C, 3 >2000, <(><<)>7, C,2 >2000 9MA. IT WAS RECOMMENDED DEFAULT TEST VALUES BE INCREASED AND THE TEST RERUN; C, 2 >2000, 13MA. THIS INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT #2182207-2009-06905. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL MONOPOLAR CONTACTS ON THE RIGHT SIDE LEAD, EXCEPT CONTACT 1, HAD IMPEDANCES GREATER THAN 2000 OHMS AND A CURRENT LESS THAN 7. THERE WAS NO ACTION PLANNED AS A RESULT OF THIS EVENT. IT WAS NOTED THAT THE PATIENT WAS RESPONDING WELL TO HIS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341439 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR