BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3092650 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07289
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALIES FOUND. IT WAS STATED ATTEMPTS WERE MADE TO DUPLICATE THE COMPLAINT DURING BENCH TESTING. IT WAS FOUND THE INS CHARGED CORRECTLY WITH NO SPACER AND 8 COUPLING BARS, A 1 CM SPACER AND 8 COUPLING BARS, AND WITH A 2 CM SPACER AND FOUR COUPLING BARS. IT WAS NOTED COUPLING AND CHARGING WERE OBSERVED WITH THE LABEL SIDE UP AND THE LABEL SIDE DOWN.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4)..

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (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 THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. IT WAS STATED THAT THE INS WAS UNABLE TO RECHARGE AFTER MULTIPLE ATTEMPTS. IT WAS STATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PHYSICIAN MODE RECHARGES (PMRS) WERE ATTEMPTED ON TWO DIFFERENT RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) FOUR ABOUT 4 SECONDS AND THEN THE SCREEN WOULD "DISAPPEAR." IT WAS STATED THAT THE REPORTER WAS ABLE TO GET A RECHARGING SCREEN WITH "NO COUPLING BOXES". NO X-RAY WAS DONE, BUT THE INS MAY HAVE BEEN FLIPPED. IT WAS STATED THAT THE INS WAS SUPERFICIAL AND NOT TILTED OR MOBILE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN X-RAY WAS DONE AND THE PHYSICIAN REPORTED THAT THE INS WAS NOT FLIPPED. THE PATIENT WAS CONTINUED TO BE UNABLE TO CHARGED. IT WAS STATED THAT THE PATIENT WAS GOING TO BE SCHEDULED FOR A REPLACEMENT WITH A NON-RECHARGEABLE SYSTEM. THE REPLACEMENT DATE HAS NOT BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194314 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 Required Intervention