BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3180631 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10659
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 3998 LOT# V014785, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3998 LOT# V003187, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3998 LOT# LB2061, IMPLANTED: 2003 (B)(6); PRODUCT TYPE LEAD (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE LEAD ¿WAS NOT WORKING.¿ IT WAS NOTED THAT THE PATIENT HAD FOUR IMPLANTS AND ¿HAD FAULTY LEADS BEFORE.¿ IT WAS FURTHER NOTED, THE PATIENT HAD EIGHT LEADS IN THE BACK AND ONE WAS NOT WORKING ¿AT ALL.¿ THE PATIENT THOUGHT ¿ANOTHER ONE WAS FAILING TOO.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LEAD PROBLEM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) HAD NO INFORMATION REGARDING THE CAUSE OF THE EVENT. IT WAS UNKNOWN IF THE CAUSE OF THE EVENT WAS DUE TO THE INS, LEADS OR EXTENSION. IT WAS NOTED, THE PATIENT HAD A SURGICAL PADDLE LEAD IMPLANTED ¿MANY YEARS AGO¿ BY THE HCP. IT WAS FURTHER NOTED, THE LAST FOLLOW UP WAS IN (B)(6) 2010 AND THE HCP HAD NOT SEEN THE PATIENT SINCE THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT INDICATED THAT THEY HAVE HAD BROKEN LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281582 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR