BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3905205 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12324
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURING REPRESENTATIVE WAS WANTING TO RESET THE ORIENTATION BECAUSE IT WAS NOT READING CORRECTLY. THE PATIENT HAD A REVISION ABOUT A MONTH PRIOR TO THE DATE OF THIS REPORT TO REPOSITION THE IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE IT WAS TOO MOBILE IN THE POCKET. THE CALLER WAS ASSISTED IN RESETTING THE ORIENTATION USING THE CLINICIAN PROGRAMMER. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382495 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention