BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3645442 · Received February 25, 2014

    Report

    Report Number
    3004209178-2014-03559
    Event Type
    Injury
    Date Received
    February 25, 2014
    Report Date
    February 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387-40, LOT# J0101928V, IMPLANTED: 2001 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7438, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 2001 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETION WAS TOO QUICK BASED ON THE REPORTER¿S KNOWLEDGE OF THE SETTINGS. THE REPORTER STATED THAT THE PATIENT HAD HAD MULTIPLE REPLACEMENTS AND INS¿S THAT DID NOT USE INTERLEAVING. THE REPORTER WANTED TO KNOW WHY THE BATTERIES WERE ONLY LASTING A COUPLE OF YEARS. THE REPORTER ONLY KNEW THAT THE PATIENT WAS PROGRAMMED MONOPOLAR WITH AN AMPLITUDE AROUND 3.0 VOLTS. EIGHT DAYS LATER, IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) THOUGHT THE INS¿S MIGHT HAVE BEEN DEPLETING TOO QUICKLY. THE PATIENT¿S SETTINGS WERE AN AMPLITUDE OF 3.5, MONOPOLAR STIMULATION, AND A PULSE RATE OF 60. REFER TO MANUFACTURING REPORT #3004209178-2012-10832 AND #3004209178-2012-10831 FOR THE PATIENT¿S ISSUES WITH HIS MOST RECENT DEVICES. REFER TO MANUFACTURING REPORT #6000032-2014-00030, #6000032-2014-00031, AND #3004209178-2014-03555 AS THE PATIENT HAD MULTIPLE REPLACEMENTS AND EACH BATTERY WAS THOUGHT TO HAVE DEPLETED TOO QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115745 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention