BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4871046 · Received June 26, 2015

    Report

    Report Number
    9614453-2015-01607
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND THE ¿#9 BALSEAL WAS DAMAGED.¿

    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 IMPLANTABLE NEUROSTIMULATOR (INS) WAS FOUND TO BE ¿DEFECTIVE¿ AT THE TIME OF IMPLANT. WHEN ATTEMPTING TO CONNECT A LEAD TO THE INS, IT WAS FOUND THE ¿LEAD DIDN¿T FIT IN ONE ENTRY¿ OF THE INS. THE OPERATING PHYSICIAN TRIED TO UNSCREW THE CONNECTION¿S SETSCREW IN ORDER TO ENLARGE THE ENTRY; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE INS WAS NOT IMPLANTED AS A RESULT OF THE EVENT. THE INS WAS REPLACED AT THE TIME OF THE PROCEDURE AND THE ISSUE WAS RESOLVED. THERE WERE NO PATIENT SYMPTOMS REPORTED INVOLVING THE EVENT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE "PATIENT WAS RECEIVING AN EFFECTIVE THERAPY" AT THE TIME OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416564 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1