BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2822824 · Received November 7, 2012

    Report

    Report Number
    9614453-2012-00171
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 9, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3550-29, PRODUCT TYPE: ACCESSORY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (MODEL#37702, SERIAL# (B)(4)) FOUND NO ANOMALIES. CONNECTOR PORT OBSERVATIONS FOUND FOREIGN MATERIAL IN PORT(S). ANALYSIS OF THE PLUG/BOOT (MODEL#3550-29) FOUND NO 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 PATIENT, WHO WAS A CASHIER, EXPERIENCED "ELECTRIC SHOCKS BECAUSE OF A DEFECTIVE CASH REGISTER." THE PATIENT THEN EXPERIENCED PAIN, A HEATING SENSATION, AT THE LEVEL OF THE IMPLANTATION SITE OF HER IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THE PATIENT'S STIMULATION "ALWAYS WORKED WELL." THE PATIENT WAS RECEIVING STIMULATION IN THE CORRECT LOCATION AND IMPEDANCES WERE "GOOD." NO INTERVENTION HAD TAKEN PLACE AS OF THE DATE OF THIS REPORT; THE PATIENT WAS TO SEE HER DOCTOR IN 2-3 WEEKS TO SEE IF THE PAIN WAS STILL PRESENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED THE SHOCKS MAINLY IN HER HANDS AND ARMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DEVICE WAS EXPLANTED. IT WAS ALSO NOTED THE PATIENT'S DEVICE WORKED WELL, "THEY ALWAYS STIMULATED THE GOOD PAINFUL TERRITORY AND IMPEDANCES WERE GOOD." DEVICE WAS EXPLANTED DUE TO ELECTRICAL SHOCKS FROM DEFECTIVE CASH REGISTER AND PAIN AT THE IMPLANT SITE. THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT. PATIENT OUTCOME WAS "FINE" AFTER REVISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention