BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3021593 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04250
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 6, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-56, LOT# V588341, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3887-56, LOT# V660848, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S EXTENSION WAS "TOO SHORT" AND WAS THEREFORE "PROPHYLACTICALLY" REPLACED WITH A LONGER EXTENSION. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED CONFIRMED THE PHYSICIAN WANTED A LONGER EXTENSION COMPONENT (OF THE IMPLANTABLE NEUROSTIMULATOR SYSTEM). THE OLD EXTENSION WAS DISCARDED AT THE TIME OF THE SURGICAL REPLACEMENT PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS 'VERY GOOD.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124221 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