BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4130484 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18025
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3986A, LOT# N117035, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3986A, LOT# N116685, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO CORRECT THE MISSING OUTCOME ATTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN WORKING FOR A YEAR. THE PATIENT WAS EXPERIENCING NO STIMULATION. IT WAS DETERMINED THAT THE INS WAS IN OVER-DISCHARGE, AND THE CAUSE OF THE OVER-DISCHARGE WAS BECAUSE OF PATIENT ERROR IN CHARGING. IT WAS NOTED THAT THE PATIENT¿S RECHARGER WAS VERSION 2.5 AND DID NOT HAVE AL TEST. IT WAS RECOMMENDED THAT A PHYSICIAN MODE RECHARGE WOULD NEED TO BE DONE. THERE WAS A POWER ON RESET (POR), AND IT WAS REMOVED AND ATTEMPTED TO JUMP START. THERE WERE ALSO TELEMETRY ISSUES. THE PATIENT WANTED THE INS REPLACED. THE MANUFACTURING REPRESENTATIVE WAS GOING TO DISCUSS THAT WITH THE PHYSICIAN. 5 DAYS LATER, THEY WERE WAITING FOR THE PATIENT TO SCHEDULE A REPLACEMENT SURGERY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608572 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention