BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3173710 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10489
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, MODEL # 37714, SN (B)(4), FOUND THE #15 BALSEAL CONNECTOR SPRING TO BE DEFORMED. A KNOWN GOOD LEAD COULD NOT BE INSERTED PAST THE #15 BALSEAL CONNECTOR. BECAUSE THE LEAD COULD NOT BE INSERTED COMPLETELY IN THE #8-15 CONNECTOR PORT IT CAUSED THE LEAD CONNECTORS NOT TO ALIGN WITH THE INS BALSEAL CONNECTORS, THUS CAUSING THE HIGH IMPEDANCE ISSUES ON THE #9-15 ELECTRODES OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IMPEDANCES GREATER THAN 10,000 OHMS WERE READ DURING IMPLANT. ELECTRODE 9-15 WAS HIGH, GREATER THAN 10,000 OHMS. THE LEAD WAS SWAPPED TO A DIFFERENT PORT ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE HIGH IMPEDANCE READING WAS STILL SEEN ON (B)(6). WHEN THESE ELECTRODES WERE PROGRAMMED, THE PATIENT FELT NO STIMULATION. THE LEAD WAS WIPED AND RE-INSERTED FOUR OR 5 TIMES AND THERE WAS STILL HIGH IMPEDANCE AND NO STIMULATION. THERE WAS NO ISSUE WITH IMPLANT. THE IMPEDANCE WAS RE-TESTED AND CONTINUED TO SHOW HIGH, OVER 10,000 OHMS. THE IMPEDANCE WAS OVER 20,000 OHMS WITH INCREASED AMPLITUDE. IT WAS NOTED ELECTRODE 8 WAS ¿FINE¿. WHEN TESTED WITH A MULTI-LEAD TRIALING CABLE, THE READINGS WERE FINE AND THE PATIENT FELT STIMULATION. THERE WAS NO ISSUE WITH IMPLANT AND THERE WERE NO ¿TW¿ ISSUES. IT WAS LATER REPORTED THE INS WAS NEVER IMPLANTED. IT WAS LATER REPORTED THERE WERE NO ADVERSE EFFECTS. THE INS WAS REPLACED AND IMPEDANCES WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273989 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 00040 YR