BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3112420 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07659
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 25, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3387-40 LOT# J0222887V, IMPLANTED: 2002 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID: 3387-40 LOT# J0220052V, IMPLANTED: 2002 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODES NO LONGER APPLY TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD "TURNED ITSELF OFF" SIX WEEKS PRIOR TO THIS REPORT. IT WAS NOTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM BECAUSE SHE "FROZE RIGHT UP." IT WAS FURTHER NOTED THAT THE PATIENT WAS HOSPITALIZED FOR ONE WEEK AND PUT IN REHABILITATION FOR FOUR WEEKS. THE REPORTER STATED THAT THE DAY PRIOR TO THIS REPORT, THE INS WAS CHECKED BY THE PATIENT'S DOCTOR AND IT WAS FOUND THAT THE INS WAS OFF. THE REPORTER STATED THAT HE DID NOT KNOW WHAT TURNED THE INS OFF. IT WAS NOTED THAT THE INS WAS TURNED BACK ON AND "AN HOUR LATER" THE PATIENT WAS FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212580 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization