BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2182183 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05163
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. SHE DID NOT RECEIVE HER EXPECTED PAIN REDUCTION FROM HER IMPLANTABLE NEUROSTIMULATOR (INS). THE PT FELL DURING THE WINTER AND BROKE THE "SCREWS" IN HER BACK. SHE STATED AN X-RAY WAS TAKEN AND INDICATED A LEAD PROBLEM. THE PT TRIED RECHARGING HER INS FOR SEVERAL WEEKS AND WAS UNABLE TO COMMUNICATE WITH HER PT PROGRAMMER OR RECHARGER. SHE COULD NOT REMEMBER THE LAST TIME SHE RECHARGED HER INS AND AN OVERDISCHARGE WAS SUSPECTED. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE145882N| IMPLANTED:| LEAD: MODEL 3777, LOT# V477971024| IMPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 246050001| ACCESSORY: MODEL 37752, LOT# NKA140237N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V447853037