BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2931379 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01037
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    September 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7438 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40 LOT# V877540, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# V877540, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE NEUROSTIMULATORS (INSS) WERE REPLACED BECAUSE THE RIGHT SIDE OF THE SYSTEM "WAS MALFUNCTIONING." IT WAS NOTED THAT THE DEVICE WAS ON BUT "WASN'T DOING ITS JOB." IT WAS REPORTED THAT THE INS REPLACEMENTS DID NOT CORRECT THE PROBLEM AND AN X-RAY DURING SURGERY SHOWED A BREAK IN THE LEAD. THE LEAD WAS NOT REPLACED DURING THE INS REPLACEMENT PROCEDURE (SEE MFR. REPORT #3004209178-2012-11659 FOR ADDITIONAL INFORMATION ABOUT THE LEAD). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR REPORT #3004209178-2013-01035. IT WAS UNCLEAR WHICH INS WAS ON THE RIGHT SIDE OF THE SYSTEM. BOTH INSS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36732 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention