BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1993865 · Received February 11, 2011

    Report

    Report Number
    3004209178-2011-01056
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    April 22, 2010
    Report Date
    January 26, 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
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELT HEAT AND PAIN AT THE IMPLANTABLE NEUROSTIMULATOR LOCATION WHEN STIMULATION WAS TURNED ON. THERE WAS NO FALL OR TRAUMA ASSOCIATED WITH THE ISSUE. THERE WAS NO REDNESS OR SWELLING BY THE POCKET. THE HCP TOOK A SKIN TEMPERATURE, AND THE POCKET SITE WAS 5% WARMER THAN SKIN ON THE OTHER SIDE. THE PT WAS PART OF A STUDY FOR SUBCUTANEOUS PLACEMENT. THE PT HAD 4 PROGRAMMED STIMULATION OPTIONS. THE AMPLITUDE VARIED; THE RATE WAS 20 HERTZ; THE PULSE WIDTH WAS 240 MICROSECONDS FOR THE QUADRIPOLAR LEAD AND 450 MICROSECONDS FOR THE OCTAD LEAD. THE IMPLANTABLE NEUROSTIMULATOR WAS MOVED ON (B)(6) 2009. IT WAS REMOVED (B)(6) 2010. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB059148V| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB060900V| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V229306038| EXPLANTED:| EXTENSION: MODEL 37082 LOT# NKB002402V| PROGRAMMER: MODEL 37743, LOT# NKE130707N| LEAD MODEL 3888, LOT# V091860| IMPLANTED:| IMPLANTED:| LEAD MODEL 3888, LOT# V196173