BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3108842 · Received May 13, 2013

    Report

    Report Number
    3004209178-2013-07556
    Event Type
    Injury
    Date Received
    May 13, 2013
    Report Date
    April 22, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377745, LOT# V000680, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 377745, LOT# V001497, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6). PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL #(B)(4)) FOUND THAT THE INS WAS RECEIVED IN AN OVERDISCHARGED STATE. THE TELEMETRY WAS RESTORED AFTER ONE FULL PHYSICIAN-MODE-RECHARGE, ALTHOUGH THE CAPACITY WAS SEVERELY REDUCED AND THE INS WAS DISCHARGING RAPIDLY. THROUGH LONGER CHARGE TIMES WITH LOWER COUPLING SOME CAPACITY WAS RESTORED SO THAT THE INS PASSED FUNCTIONAL TESTING. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE BATTERY WAS LAST RECHARGED WHILE IMPLANTED ON (B)(6) 2008. IT WAS ONLY RECHARGED TO 3.720 VOLTS AND DEPLETED TO THE "LOCK" MODE ON (B)(6) 2008. IT HAD NOT BEEN RECHARGED UNTIL IT WAS DONE IN THE RETURNED PRODUCT ANALYSIS LAB. ANALYSIS OF THE EXTENSION (SERIAL # (B)(4)) FOUND NO ANOMALIES. ANALYSIS OF THE EXTENSION (SERIAL # (B)(4)) FOUND THAT THE PROXIMAL END HAD NOT BEEN COMPLETELY SEATED IN THE INS CONNECTOR PORT. THE EXTENSION IS ELECTRICALLY OKAY, BUT IT WAS NOT COMPLETELY SEATED IN THE #8-15 CONNECTOR PORT OF THE INS CAUSING NO OUTPUT ON ANY ELECTRODE PAIRS USING ELECTRODES 9, 10, OR 11. ANALYSIS OF BOTH OF THE LEADS FOUND THAT THEY HAD BOTH BEEN SEGMENTED. A FUNCTIONALITY TEST OF THE EXTENSIONS AND LEADS FOUND THAT THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS. A SET SCREW IMPRESSION ON THE EXTENSION WAS TOO PROXIMAL, INDICATING THAT THE EXTENSION WAS NOT COMPLETELY SEATED INT EH #8-15 CONNECTOR PORT OF THE INS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR DEVICE EXPLANTED DUE TO AN INFECTION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD "CHRONIC INFECTIONS" AND A "NON-FUNCTIONING UNIT". ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209809 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention