BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3660994 · Received March 5, 2014

    Report

    Report Number
    9614453-2014-00433
    Event Type
    Injury
    Date Received
    March 5, 2014
    Report Date
    March 21, 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

    ANALYSIS OF THE LEAD (LOT # 0207651138) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THAT THE STIM LEAD BODY HAD BEEN CUT THROUGH. ANALYSIS OF THE IMPLANTABLE PULSE GENERATOR (S/N (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE MLTC (S/N UNKNOWN) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THAT FOREIGN MATERIAL WAS PRESENT AT THE DISTAL CONNECTOR END OF THE STIM SCREENING CABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, LOT# 0207651138, PRODUCT TYPE LEAD. PRODUCT ID 37081-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37081-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 355531, SERIAL# UNKNOWN, PRODUCT TYPE SCREENING DEVICE, PRODUCT ID 37081-40, SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID 355531, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    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 THAT AFTER INITIAL SUCCESSFUL USE, THE PATIENT¿S SYSTEM DID NOT PERFORM AS EXPECTED. IT WAS STATED THAT IT WAS UNCLEAR WHETHER IT WAS DUE TO THE IMPLANTED PRODUCTS. IT WAS REPORTED THAT IMPEDANCE TESTING AND REPROGRAMMING WERE PERFORMED. IT WAS STATED THAT THE PRODUCT ISSUE HAD NOT BEEN RESOLVED, AND THAT THE CAUSE OF THE ISSUE HAD NOT BEEN DETERMINED. IT WAS STATED THAT EXPLANT WAS REQUIRED AS A RESULT OF THE EVENT. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT, AND THAT THE PATIENT WAS LISTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER IMPLANT, STIMULATION HAD NEVER BEEN OPTIMAL (LEGS ONLY, WHEN BEFORE ALSO BACK WAS COVERED). IT WAS STATED THAT NO LEAD DISPLACEMENT WAS FOUND. IT WAS REPORTED THAT REPROGRAMMING HAD BEEN ATTEMPTED BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT IMPEDANCE MEASUREMENTS WERE 554-741 POST-OP AND 862-1510 AT A LATER APPOINTMENT. IT WAS REPORTED THAT THE ENTIRE IMPLANTED SYSTEM WAS EXPLANTED, NOT REPLACED, AND THE PATIENT WAS CURRENTLY NOT RECEIVING THERAPY. IT WAS NOTED THAT DURING THE EXPLANT PROCEDURE, THE LEAD WAS DAMAGED APPROXIMATELY 5 CM BELOW THE ELECTRODES. IT WAS NOTED THAT EXPLANTED DEVICES WOULD BE RETURNED TO THE MANUFACTURER. IT WAS NOTED THAT DURING THE ¿TESTPHASE¿ FLUID GOT INSIDE THE MLTC (MULTI-LEAD TRIALING CABLE) AND CAUSED THE SYSTEM TO SHUT DOWN. IT WAS STATED THAT THE FLUID WAS REMOVED AND IMPEDANCES WERE MEASURED AND FOUND TO BE IN RANGE. IT WAS STATED THAT THE MLTC WOULD ALSO BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132407 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention