BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 5815583 · Received July 22, 2016

    Report

    Report Number
    9614453-2016-04672
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 28, 2016
    Report Date
    July 22, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 74001, LOT# N555736, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: ADAPTER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED VIA THE COMPANY REPRESENTATIVE (REP) THAT THERE WAS AN ABNORMAL RESISTANCE VALUE. THE PATIENT UNDERWENT REPLACEMENT OPERATION TO CHANGE FROM A SYNERGY TO PRIME ADVANCED. TWO ADAPTERS WERE USED BUT ONLY THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. THE VALUE WAS NORMAL WHEN THE RESISTANCE VALUE WAS MEASURED DURING THE PROCEDURE, BUT WHEN IT WAS MEASURED AT THE WARD AN ABNORMAL VALUE IN ELECTRODE 8 WAS DETECTED. OTHER ELECTRODE RESISTANCE VALUES WERE INCREASED ACROSS THE BOARD. ELECTRODES IN QUESTION WERE: 0-3, 8-11. THE DEVICE SETTINGS WERE: 1CH 1.5V, 2CH 0.55V, 210 PULSE WIDTH, 40HZ, BIPOLAR, +1, +5, -2, -6. AN EXTERNAL FACTOR THAT MAY HAVE CAUSED THE EVENT WAS ADAPTER/DEVICE CONNECTION FAILURE, BLOOD ADHESION. THE ACTION TAKEN TO RESOLVE THE ISSUE WAS OUTPUT WAS INCREASED, THEN CONDUCTION AND THRESHOLD WAS CHECKED. STIMULATION WAS FELT AT 5-6V. SETTINGS WERE CHANGED TO WHAT THEY WERE WITH THE PREVIOUS INS. PROGRESS WAS CURRENTLY BEING MONITORED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. NO SURGICAL INTERVENTION OCCURRED NOR WAS PLANNED. THERE WAS NO INJURY OR IMPACT TO THE PATIENT. NO SYMPTOMS REPORTED. THE REP REPORTED THREE WEEKS LATER THAT THE IMPEDANCE MEASUREMENTS WERE: 0: REFERENCE 1: 3233 8: >10000 2: 4909 9: 8258 3: 5433 10: 5785 4: >10000 11: 5739 5: >10000 12: >10000 6: >10000 13: >10000 7: >10000 14: >10000 THE PATIENT WAS DISCHARGED AND THERE WAS NO ADDITIONAL INFORMATION. THE DEVICE REMAINED IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469665 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1