BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3191323 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10927
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 6, 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

    PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: 1994 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39286, LOT# UK6122327, IMPLANTED: (B)(6) 1994, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE LEAD BODY WAS CUT THROUGH. ANALYSIS OF THE ANCHORS FOUND NO ANOMALY.

    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 LATER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED. NORMAL BATTERY DEPLETION WAS NOTED. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND A SHOCKING OR JOLTING SENSATION. IT WAS FURTHER NOTED THAT THE PATIENT HAD INTERMITTENT ¿ON AND OFF¿ STIMULATIONS A FEW TIMES IN A WEEK. THE CHARGE LEVEL WAS UNKNOWN WHEN THIS OCCURRED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE SCHEDULED OR CYCLED THERAPY. IT WAS NOTED THAT THIS HAD BEEN HAPPENING FOR TWO WEEKS PRIOR TO REPORT. NO FALLS AND TRAUMA WERE REPORTED. IT WAS NOTED THAT THE SHOCKING AT POCKET COULD NOT BE REPRODUCED. IT WAS NOTED THAT THIS HAPPENED ONCE A WEEK FOR ONE YEAR. IT WAS NOTED THAT IMPEDANCES WERE WITHIN RANGE AND THAT THE X-RAY "LOOKED GOOD." ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO APPARENT MALFUNCTIONS OBSERVED AND NO KNOWN CAUSE OF THE ISSUE. NO SPECIAL INTERVENTIONS WERE TAKEN. IT WAS NOTED THAT AN IMPEDANCE CHECK WAS NEGATIVE FOR ANY POSSIBLE SHORT OR OPEN CIRCUITS. THE PATIENT CONTINUED TO RECEIVE EFFECTIVE THERAPY ¿AS THE REPORTED INCIDENCES WERE FEW IN NUMBER AND HAPPENED RATHER INFREQUENTLY.¿ THE REPORTER STATED THAT THEY BELIEVE THAT THE PATIENTS ¿ON-OFF¿ ISSUE COULD BE RELATED TO POSITIONAL CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290872 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention