BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6241940 · Received January 11, 2017

    Report

    Report Number
    3004209178-2017-00632
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3389S-40, LOT# V742351, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V742351, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED SHORT CIRCUIT AND HIGH IMPEDANCES. IT WAS STATED THAT THIS SHORT MAY HAVE BEEN THERE SINCE THE INITIAL LEAD PLACEMENT, WITH THE IMPLANT INTERROGATED ON DATE NOTIFIED. THE PATIENT HAS MULTIPLE GROUPS AND CAN SWITCH SO THAT CONTACT 9 IS NOT IN USE, WITH THE ISSUE UNRESOLVED AT THE TIME OF THE REPORT. INTERROGATION OF THE DEVICE SHOWED C<(>&<)> 3 = 13686, 1 <(>&<)> 3 = 14176, 0 <(>&<)> 3 = 14840, 2 <(>&<)> 3 = 13805, AND 9 <(>&<)> 11 = 38. THE PATIENT'S INDICATION FOR IMPLANT IS PARKINSON'S DUAL AND MOVEMENT DISORDERS.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE PATIENT FIRST STARTED EXPERIENCING THE SHORT CIRCUIT ON CONTACT 9 ON (B)(6) 2016. IT WAS STATED THAT THE SHORT WAS THERE PRIOR TO THE BATTERY/IMPLANTABLE PULSE GENERATOR (IPG) CHANGE AND COULD BE IN THE LEAD. THE PATIENT IS NOT CURRENTLY USING CONTACT 9, AND THE HCP IS TO TEST AT 3V ON THE NEXT VISIT TO SEE IF THE HIGH IMPEDANCES ARE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25042 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR