BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3950059 · Received July 22, 2014

    Report

    Report Number
    9614453-2014-01547
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 1, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    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

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EXPLANT WAS PLANNED FOR THE LAST WEEK IN SEPTEMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) PREMATURELY DEPLETED. IT WAS NOTED THE INS REACHED END OF LIFE. IT WAS FURTHER NOTED THE DATE OF EXPLANT WAS PLANNED FOR 2014-(B)(6). THE REPORTER STATED THEY HAD TO CHANGE THE INS AS SOON AS POSSIBLE BECAUSE THE INS WAS ALMOST OFF. IT WAS NOTED THAT IMPEDANCE TESTING WAS DONE. IT WAS FURTHER NOTED THAT NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. IT WAS NOTED THAT THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES WERE NORMAL ¿MINUS 1000.¿ THE REPORTER STATED THE EXPLANT WOULD BE ¿ABOUT (B)(6).¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429064 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention