BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2894364 · Received January 3, 2013

    Report

    Report Number
    9614453-2013-00005
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 11, 2012
    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). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNABLE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE RECHARGER CAN CONNECT WITH THE INS BUT IT DID NOT CHARGE. THERE WERE ZERO BARS OUT OF EIGHT, MEANING THAT THE RATE OF CHARGE TRANSFER WAS ZERO. X-RAYS WERE TAKEN AND THEY DID NOT SHOW AN INS FLIP. A DIFFERENT RECHARGER WAS USED AND GOT THE SAME RESULT. A BATTERY OVER DISCHARGE WAS SUSPECTED. A SURGERY WAS PLANNED WHERE THEY WERE GOING TO DO INTRAOPERATIVE TESTING WITH THE RECHARGER. IF THAT IS NOT SUCCESS THE INS WILL BE REPLACED. IT WAS REPORTED THAT THERE WERE NO PATIENT INJURIES OR SYMPTOMS RELATED TO THE EVENT AND THE PATIENT WAS ALIVE WITHOUT INJURY OR ADVERSE EVENT. NO FURTHER INFORMATION WAS PROVIDED. IF MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE INS WAS ABLE TO "TURNED" AND COULD BE RECHARGED. THE PROBLEM WAS REPORTED AS "SOLVED" WITH THE INS REPORTED AS WORKING WITHOUT ANY PROBLEMS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention