BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XRESTORE PRIME ADVANCED

    MDR report key: 1052626 · Received May 27, 2008

    Report

    Report Number
    3004209178-2008-02805
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    August 21, 2007
    Report Date
    June 8, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN ANS DEVICE. THE PHYSICIAN RETAINED THE EXPLANTED DEVICE AND PLANNED TO "REVIEW THE UPCOMING DEVICE FUNCTIONALITY" AND WOULD LET MEDTRONIC KNOW THE RESULTS. THE PHYSICIAN STATED THAT HE WOULD "COMPARE HIS RESULTS TO ALL THE ONES HE FIXED A FEW YEARS AGO", NO DETAILS WERE PROVIDED. THE EXPLANTING HCP STATED THE DEVICE WAS EXPLANTED BECAUSE THE "DEVICES ARE NOT WORKING AS ADVERTISED". THE MEDTRONIC REP HAD NOT BEEN CONTACTED REGARDING THE SPECIFIC PROBLEM OR TO ASSIST WITH TROUBLESHOOTING PRIOR TO DEVICE EXPLANT.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. ON (B)(6) 2008, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER COMPANY'S DEVICE. THE PHYSICIAN RETAINED THE EXPLANTED DEVICE AND PLANNED TO "REVIEW THE UPCOMING DEVICE FUNCTIONALITY" AND WOULD LET MANUFACTURER KNOW THE RESULTS. THE PHYSICIAN STATED THAT HE WOULD "COMPARE HIS RESULTS TO ALL THE ONES HE FIXED A FEW YEARS AGO"; NO DETAILS WERE PROVIDED. THE EXPLANTING HCP STATED THE DEVICE WAS EXPLANTED BECAUSE THE "DEVICES ARE NOT WORKING AS ADVERTISED". THE MEDTRONIC REPRESENTATIVE HAD NOT BEEN CONTACTED REGARDING THE SPECIFIC PROBLEM OR TO ASSIST WITH TROUBLESHOOTING, REPROGRAMMING, OR TO RUN IMPEDANCE CHECKS PRIOR TO DEVICE EXPLANT. THE PATIENT REPORTED ON (B)(6) 2016, THAT IN RECOVERY ON (B)(6) 2007, THE ELECTRODES WERE COMING OUT OF THE SKIN. THEY PUSHED THE ELECTRODES BACK IN AND TAPED OVER THEM, STATING IT WAS JUST A NIGHTMARE. LATER THE STIMULATOR AND LEADS WERE ALL TAKEN OUT/REMOVED. INDICATION FOR USE INCLUDED NON-MALIGNANT PAIN, AND OTHER NON-MALIGNANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XRESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO., 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT # V047854005| LEAD: MODEL 3778, LOT # V047854003| IMPLANTED:| EXPLANTED:| EXPLANTED: