BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2981424 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03128
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008,PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECOND IMPLANTABLE NEUROSTIMULATOR (INS) WAS NEEDED DURING AN ELECTIVE INS REPLACEMENT SURGERY BECAUSE THE FIRST INS WAS SHOWING OUT OR RANGE IMPEDANCES. THE SECOND INS SHOWED IMPEDANCES THAT WERE OUT OF RANGE FOR ELECTRODES 8-15, LIKE THE FIRST INS. THE DOCTOR DECIDED TO USE THE SECOND INS DESPITE THE IMPEDANCES. POST-OPERATION THE GOOD ELECTRODE (8) AND THE OTHER LEAD WERE USED FOR THERAPY. THE DESIRED COVERAGE WAS ACHIEVED. IT WAS NOTED THAT IMPEDANCES WERE STILL SHOWING OUT OF RANGE POST-OPERATION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY OR ADVERSE EVENT. ALSO, THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. REFER TO MANUFACTURER REPORT # 3004209178-2013-03127, FOR INFORMATION ON THE FIRST INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84107 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