BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2915448 · Received January 15, 2013

    Report

    Report Number
    3004209178-2013-00587
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    December 20, 2012
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: LONGEVITY ESTIMATE, BASED ON THE PATIENT SETTINGS FROM INITIAL REVIEW TAKEN FROM THE DEVICE WHEN RECEIVED, SHOWED NORMAL BATTERY DEPLETION. IT WAS ALSO NOTED THAT THE SHIELD/CAN WAS SCRATCHED, THE SETSCREW WAS BACKED OUT TOO FAR, AND THERE WAS FOREIGN MATERIAL IN THE PORT AND UNDER THE COVER. THERE WERE NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED DUE TO "FAILED GENERATOR POSITION AND BATTERY LIFE." THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22896 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention