BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4935052 · Received July 23, 2015

    Report

    Report Number
    3004209178-2015-13945
    Event Type
    Injury
    Date Received
    July 23, 2015
    Report Date
    July 2, 2015
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL REVIEW DETERMINED THAT (B)(4) NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 3550-39, LOT# N171449, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3550-39, LOT# N137575, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3888-45, LOT# V302548, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V331906, PRODUCT TYPE: LEAD. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3888-45, LOT# V331906, PRODUCT TYPE: LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3888-45, LOT# V260571, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S FIRST BATTERY WORKED FROM 2009 TO 2012 BUT THEN QUIT WORKING AND THEY HAD IT REPLACED; THEY WEREN¿T SURE WHY. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AS A RESULT THAT THE STIMULATOR QUIT WORKING THE PATIENT EXPERIENCED NO STIMULATION. IT WAS UNKNOWN WHAT CIRCUMSTANCES LED TO THE DEVICE STOP WORKING. THE STEPS TAKEN TO RESOLVE THE DEVICE STOP WORKING WERE THE PATIENT CALLED THE DOCTOR¿S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480532 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention