BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4190254 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20102
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# V714493, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V706699, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LEAD REPLACEMENT DUE TO THE PATIENT¿S PAIN HAVING CHANGED. THE HEALTHCARE PROVIDER (HCP) WAS REMOVING 2 PERIPHERAL NERVOUS SYSTEM LEADS AND REPLACING THEM WITH 2 EPIDURAL LEADS FOLLOWING A SUCCESSFUL TRIAL. THE PLAN WAS TO USE THE PATIENT¿S EXISTING IMPLANTABLE NEUROSTIMULATOR (INS) SINCE IT WAS ONLY 3 YEARS OLD. WHEN ADVANCING THE LEADS, HE COULD NOT ADVANCE THE LEAD INTO THE BOTTOM 8-15 PORT. IT WAS STATED THAT THE BOTTOM PORT SHOULD¿VE HAD A PORT PLUG IN IT SINCE THE PREVIOUS CONFIGURATION WAS 2 QUADS INTO AN ADAPTOR. THE PLUG DID NOT APPEAR TO BE IN THE BOTTOM WHEN HE REMOVED THE INS FROM THE POCKET, BUT HE COULD NOT ADVANCE THE LEAD INTO THE PORT. IT WAS UNKNOWN IF THE INS HAD A PLUG FROM THE PREVIOUS SURGERY BUT IT WAS SUSPECTED TO AS THIS IS NORMAL FOR PHYSICIANS TO DO. THE HCP TRIED TO UNSCREW AND READVANCE WITH NO SUCCESS. IT WAS THEN DECIDED TO REPLACE THE INS. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PATIENT WAS NOTED TO BE DOING FINE AND RECEIVING EFFECTIVE THERAPY. IT WAS UNKNOWN IF THERE WAS A (B)(6) OR GREATER SYMPTOM REDUCTION FROM BEFORE THE IMPLANT. NO FURTHER FOLLOW-UP WAS REQUIRED AS NO PATIENT SYMPTOMS WERE REPORTED AND THE PATIENT WAS STATED TO BE RECEIVING EFFECTIVE THERAPY. THIS EVENT WILL BE UPDATED ONCE THE ANALYSIS IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668521 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 00049 YR