BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2882396 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12114
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    July 31, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_PTM_PROG, PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# NHU173128V, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# UNKNOWN, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# UNKNOWN, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE STATUS LIGHTS ON THE BACK OF THE PATIENT PROGRAMMER WERE ASSESSED, BUT NO LIGHTS WERE CONFIRMED. IT WAS STATED THE PATIENT "DIDN'T THINK THEY HAVE EVER CHANGED THE PATIENT PROGRAMMER BATTERIES." IT WAS FURTHER STATED THAT THE PATIENT HAD BEEN LETHARGIC AND WAS "STUMBLING" AROUND FOR THE ABOUT THREE DAYS. IT WAS REPORTED THAT THE PATIENT "BELIEVED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) MAY NEED TO BE REPLACED." A MINOR SHOCK/BUZZING SENSATION COULD BE FELT BY THE PATIENT, AS WELL. IT WAS NOTED THAT REPROGRAMMING HAD BEEN COMPLETED ABOUT SIX MONTHS AGO AND THE SYMPTOMS "GOT BETTER AFTER THAT." IN ADDITION, IT WAS NOTED THAT THE PATIENT WAS GOING TO HAVE ANOTHER INS IMPLANTED IN THEIR CHEST ON (B)(6) 2012. IT WAS FURTHER REPORTED THAT THE PATIENT LOST THERAPEUTIC EFFECT. IT WAS INDICATED THAT THE PATIENT HAD TROUBLE WITH SHAKING AND DIFFICULTY WALKING THE PAST FOUR DAYS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1