BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2992436 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03421
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 19, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3587A, LOT# L20853, IMPLANTED: (B)(6) 1992, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DID NOT FEEL STIMULATION ON ANY ELECTRODES. THE REPORTER STATED THAT IMPEDANCES RANGED FROM 1736 OHMS TO 4221 OHMS. IT WAS REPORTED THAT A PATIENT ALSO DIDN'T GET GOOD THERAPY WITH A PREVIOUS DEVICE (SEE MFR. REPORT 3004209178-2013-03418). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT HAD BEEN 12 DAYS SINCE THE REPLACEMENT TOOK PLACE WHEN THE PATIENT HAD NO STIMULATION SENSATION. THE HIGHEST IMPEDANCE MEASURED WAS 4535 OHMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PLAN WAS TO REPLACE THE LEADS AT A LATER DATE. THE PATIENT WAS NOT RECEIVING THERAPY AS OF THE DATE OF THIS REPORT. A SECOND FOLLOW UP WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97105 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