BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3920082 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-12676
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    March 23, 2018
    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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF PRODUCT ID (B)(4) SERIAL# (B)(4) IMPLANTED: (B)(4) 2014: PRODUCT TYPE LEAD INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: (B)(4) SERIAL/LOT #: (B)(4) UBD: (B)(4) 2017, UDI#: (B)(4) UPDATE. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT DID NOT HAVE A REVISION THUS NO SERIOUS INJURY OCCURRED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE. X-RAYS WERE TAKEN. A LEAD REVISION WAS GOING TO BE SCHEDULED. THE CAUSE OF THE MIGRATION WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT HAD LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S REVISION HAD NOT BEEN SCHEDULED YET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THEY HAD JUST ABOUT 100% WHOLE BODY RELIEF WHICH LASTED ABOUT TWO MONTHS AND THEN THE WIRE SLIDE DOWN TO THE MIDDLE OF THEIR BACK. THE PATIENT STATED IT WAS NOW CAUSING THEM INCREDIBLE PAIN AND THEY COULDN¿T EVEN GET THE BATTERY TO CONNECT TO GET ANYTHING OUT OF IT. THE PATIENT WANTED TO GET THE DEVICE FIXED BUT HAD BEEN UNABLE TO GET INSURANCE TO PAY FOR IT. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396194 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention