BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2102709 · Received May 19, 2011

    Report

    Report Number
    3004209178-2011-03676
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF BY ITSELF, INTERMITTENTLY, DURING THE PREVIOUS COUPLE OF WEEKS. IMPEDANCE READINGS WERE WITHIN THE NORMAL RANGE AND THE INS WAS CHARGED TO FIFTY PERCENT. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED. NO PT SYMPTOMS OR INJURY WERE REPORTED. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADDITIONAL INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male ADAPTER: MODEL 74001, LOT# N207548| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495, LOT# XR0065545N| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LOT# *UK6078695| PROGRAMMER: MODEL 37743, LOT# NKE128575N| RECHARGER: MODEL 37752, LOT# NKA129255N| STIM ACCESSORY: MODEL 3550-29, LOT# N199454| STIM ACCESSORY: MODEL 37092, LOT# 223510001| UNKNOWN CONVERSION TYPE: MODEL LEADN| IMPLANTED:| LOT# *UK6078695| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| RECHARGER: MODEL 37752, LOT# NKA129255N| UNKNOWN CONVERSION TYPE: MODEL LEADN,| IMPLANTED:| EXTENSION: MODEL 7495, LOT# XR0065545N| STIM ACCESSORY: MODEL 3550-29, LOT# N199454| ADAPTER: MODEL 74001, LOT# N207548| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 223510001| PROGRAMMER: MODEL 37743, LOT# NKE128575N