BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4484227 · Received February 4, 2015

    Report

    Report Number
    3004209178-2015-01744
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    September 5, 2012
    Report Date
    January 14, 2015
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT # V882270) FOUND NO ANOMALY. ANALYSIS OF THE LEAD (LOT # VA00L3S) FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE LEAD (LOT # VA00L3S) FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE LEAD (LOT # V653974) FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# VA00L3S, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# V882270, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3888-45, LOT# V653974, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, 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 THE PATIENT HAD ISSUES WITH ONE OF THEIR PNS LEADS. EVEN DURING INTRA-OPERATIVE TESTING BEFORE THE SYSTEM WAS IMPLANTED IN 2012 THE PATIENT WAS UNABLE TO FEEL STIMULATION AT 10 VOLTS. IMPEDANCE TESTING AND REPROGRAMMING WERE BOTH PERFORMED WITHOUT SUCCESS. THE PATIENT STILL WANTED THE DEVICE IMPLANTED. ON (B)(6) 2015 THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT NOTED TO BE DOING WELL AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79935 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention