BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2882267 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12106
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    August 6, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# UNKNOWN, EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4): ANALYSIS OF THE EXTENSION REVEALED THERE WAS NO ANOMALY FOUND. ANALYSIS OF THE LEAD REVEALED THE STIMULATION BODY CONDUCTOR WAS BROKEN WITHIN 10 CM OF CONNECTOR AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD AND EXTENSION WERE EXPLANTED. IT WAS NOTED THERE WAS A LEAD/EXTENSION/ACCESSORY BREAKAGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT THE CAUSE OF THE EVENT WAS A LEAD FRACTURE. THERE WAS A SURGICAL REVISION ON (B)(6)-2012 TO REPLACE THE LEFT LEAD AND EXTENSION. THERE WAS A RADIOLOGICAL REVIEW ON (B)(6)-2012 THAT INDICATED A LEAD FRACTURE. PATIENT HOSPITALIZATION WAS REQUIRED. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 Hospitalization| R ..