BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3298887 · Received August 20, 2013

    Report

    Report Number
    3004209178-2013-14883
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Report Date
    July 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377660, LOT# V000961, IMPLANTED: 2005-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 377660, LOT# V000961, IMPLANTED: 2005-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377660, LOT# V000961, IMPLANTED: 2005-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 377660, LOT# V000961, IMPLANTED: 2005-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    WHEN CONTACT FOR FOLLOW UP INFORMATION, THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT SINCE THEY HAD TOOK OVER THE CARE OF THE PATIENT IN (B)(6) 2013, THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN WORKING. THE CAUSE OF THE ISSUE WAS UNKNOWN AND IT WAS NOTED THAT THE PATIENT HAD NOT ASKED THEM TO ADDRESS THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD THE STIMULATOR SYSTEM OFF FOR FIVE YEAR BECAUSE IT NEVER HELPED. IT WAS NOTED THAT IT NEVER PROVIDED ANY RELIEF SO THE PATIENT TURNED IT OFF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN DEAD FOR 3 TO 4 YEARS BUT THE PATIENT COULD NOT REMEMBER EXACTLY HOW LONG IT HAD BEEN. IT WAS NOTED THAT THE REPORTER THOUGHT THAT THE PATIENT WAS NOT USING THE STIMULATION BECAUSE IT WAS NOT WORKING. IT WAS NOTED THAT THEY MAY EXPLANT THE INS AND PUT IN A PUMP INSTEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE DID A PHYSICIAN RESET SIX TIMES AND NEVER GOT THE BATTERY TO COME BACK ON. IT WAS NOTED THAT THE PATIENT WAS CONSIDERING GETTING THE STIMULATOR EXPLANTED BECAUSE IT HAD NEVER WORKED. IT WAS NOTED THAT THE PATIENT WAS GOING TO GET A PUMP TRIAL IN A COUPLE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401669 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR