BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2841990 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10629
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-33, LOT# J0333780V, IMPLANTED: 2003 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ONE LEAD THAT WAS NOT FUNCTIONING CAUSING HER TO NOT GET COMPLETE STIMULATION COVERAGE. THE PATIENT WAS REFERRED TO A PHYSICIAN FOR A LEAD REVISION.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED, THE PATIENT HAD BEEN SEEN ON (B)(6) 2012. THE PATIENT HAD TWO QUAD LEADS WITH HIGH IMPEDANCE ON ONE ELECTRODE. REPROGRAMMING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. LEAD REVISION WAS DISCUSSED BUT THE PATIENT WAS HESITANT. PATIENT HAD RESTLESS LEG SYNDROME AND THE STIMULATION IRRITATED THAT CONDITION. AT THE TIME OF REPORT NO REVISION WAS PLANNED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT AS A LEAD BREAK. SYMPTOMS WERE REPORTED AS INCREASED. NO SURGICAL IN TERVENTION HAD BEEN PERFORMED. NO HOSPITALIZATION WAS REQUIRED DUE TO EVENT. THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention