BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3020737 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04219
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3487A-56 LOT# V931748, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3487A-56 LOT# V984143, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A-56, LOT# V931748, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3487A-56, LOT# V984143, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "LOSS OF STIMULATION/THERAPEUTIC EFFECT." IT WAS FURTHER REPORTED THAT THE "THERAPY WAS NO LONGER HELPING THE PATIENT." THE PATIENT WAS SCHEDULED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR EXPLANTED ON (B)(6) 2013 AND REPLACED WITH AN IMPLANTABLE PUMP. IT WAS NOTED THAT THE PATIENT HAD SUCCESSFULLY TRIALED A PUMP PRIOR TO REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION OBTAINED FROM THE HEALTHCARE PROFESSIONAL (HCP) CONFIRMED THAT THE INS DID NOT HELP THE PATIENT¿S PAIN SYMPTOMS AND THAT THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A SUCCESSFUL EXPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IMPLANT OF A PAIN PUMP. THE PATIENT WAS REPORTEDLY DOING FINE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123260 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