BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2396944 · Received January 4, 2012

    Report

    Report Number
    3004209178-2012-00049
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANTLY SHORTER INTERVALS DURING THE LAST SIX MONTHS. THE PATIENT RECHARGED WHEN THE BATTERY METER SHOWED 25% OR LESS. THE RECHARGING INTERVAL WAS PREDICTED TO BE 7 DAYS, BUT WAS ONLY 1 DAY. THE EFFECT OF THE NEUROSTIMULATION WAS WORSE SINCE THE LAST REVISION 6 MONTHS AGO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE RECHARGER INDICATED THAT RECHARGING SESSIONS OCCURRED ON (B)(4) 2011 (124MIN), (B)(4) 2011 (84MIN), (B)(4) 2011 (147MIN), AND TWICE ON (B)(4) 2011 (163 AND 0 MIN). RECHARGE HISTORY OBTAINED FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED THE EXACT SAME RECHARGE SESSIONS, WITH THE EXCEPTION OF AN ADDITIONAL SESSION ON (B)(4) 2011 (APPROXIMATELY 57 MIN). THE INFORMATION OBTAINED FROM THE INS AND RECHARGER CONTRADICTED THE PATIENT'S INDICATION THAT SHE HAD BEEN RECHARGING DAILY. IMPEDANCES DID NOT INDICATE A PROBLEM. THE PHYSICIAN WAS PLANNING A REVISION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AS OF (B)(4) 2012 ALL PRODUCTS WERE STILL IMPLANTED OR IN USE BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention