BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 5078380 · Received September 15, 2015

    Report

    Report Number
    3004209178-2015-17988
    Event Type
    Injury
    Date Received
    September 15, 2015
    Report Date
    August 21, 2015
    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
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# V006367, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    A CONSUMER REPORTED THE PATIENT'S PRIMARY CELL IMPLANTABLE NEUROSTIMULATORS (INS) WERE DEPLETING FASTER THAN EXPECTED. THE PATIENT WAS GOING THROUGH BATTERIES FASTER THAN THEY THOUGHT SO THEY HAD BEEN TALKING TO THEIR HEALTH CARE PROVIDER (HCP) ABOUT THE RECHARGEABLE BATTERIES. THIS STARTED WITH THEIR IMPLANT IN 2009 AND THE PATIENT WAS READJUSTED WITH A HIGHER VOLTAGE THAT MADE THE BATTERY LIFE SHORTER. THE INSS WERE ONLY LASTING ABOUT A YEAR AND A HALF AND THIS HAD BEEN HAPPENING GRADUALLY. THE PATIENT DID NOT HAVE ANY FALLS OR TRAUMAS. THE PATIENT'S INDICATION FOR USE IS ESSENTIAL TREMOR. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #3004209178-2015-17987.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609033 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention