BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5959934 · Received September 19, 2016

    Report

    Report Number
    3004209178-2016-19153
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    August 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED BOTH LEADS WERE NOT FRACTURED. THE LOSS OF STIMULATION WAS NOT CONSIDERED TO BE CAUSED BY THE LEAD FRACTURE AS THERE WAS NO ANOMALY WITH THE IMPEDANCE, BUT RATHER DEVICE DAMAGE SUCH AS A FAULTY CIRCUIT AFTER THE IMPLANTED SITE WAS HIT WHEN THE PATIENT FELL DOWN AND COLLIDED WITH THE WHEEL CHAIR. REGARDING THE INS, THE LOSS OF STIMULATION OCCURS INTERMITTENTLY BUT THE INS WAS STILL CONTINUOUSLY USED. NO SURGICAL INTERVENTION WAS OR WILL BE PLANNED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED VIA THE COMPANY REPRESENTATIVE (REP) THAT THE PATIENT FELL DOWN AND HAD A COLLISION WITH A WHEEL CHAIR AND IMPLANTABLE NEUROSTIMULATOR (INS) SITE. A LOSS OF STIMULATION OCCURRED AFTERWARDS. AT AN OUTPATIENT DEVICE CHECK ON THE DAY OF THIS REPORT IMPEDANCES WERE MEASURED AND ELECTRODES WERE CHANGED FOR USE TO DELIVER STIMULATION. AFTER PARESTHESIA WITH APPROXIMATELY 9V OCCURRED, A LOSS OF STIMULATION OCCURRED IN SEVERAL MINUTES. THERE WAS DAMAGE OF THE INS ELECTRONIC CIRCUIT, LEAD FRACTURE. THE DEVICE SETTINGS WERE: 4-5V, 1/2 CH (450PW), 3CH (1,000PW), EXACT IMPEDANCE UNKNOWN BUT VALUE WAS NOT ABNORMAL, 5HZ, BIPOLAR, ANODE 1CH (ELECTRODES 2 AND 3), ANODE 2CH (ELECTRODE 6), ANODE 3CH (ELECTRODE 12), CATHODE 1CH (ELECTRODES 0 AND 1), CATHODE 2 CH (ELECTRODES 3, 4, AND 5), CATHODE 3CH (ELECTRODES 8-11 AND 13-15). X-RAY IMAGES WERE PERFORMED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. NO SURGICAL INTERVENTION OCCURRED, NOR WAS PLANNED. THE PHYSICIAN'S OBSERVATION ABOUT SEVERITY WAS CONSIDERED SEVERE. NO SURGICAL INTERVENTION OCCURRED, UNKNOWN IF PLANNED. THERE WAS INJURY TO THE PATIENT. TEN DAYS LATER THE REP REPORTED THAT THE OUTPUT WAS INCREASED AND STIMULATION HAS BEEN DELIVERED. ALTHOUGH INTERMITTENT LOSS OF STIMULATION SOMETIMES OCCURS, THE SYSTEM WAS CONTINUOUSLY USED AT THE MOMENT.

    Description of Event or Problem · 1

    THE REP ADDITIONALLY REPORTED THAT THE PATIENT WAS SCHEDULED TO BE SEEN ON (B)(6) 2016. IT WAS NOTED THAT THERE WAS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611292 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR