BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2023465 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01753
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED SHOCKING AND POCKET STIMULATION. THE PT WAS SEEN IN CLINIC. IMPEDANCES WERE OK. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL 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 39 YR Male Hospitalization| R| S ACCESSORY: MODEL 37752, LOT # NKA150217N.| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB085778V.| EXTENSION: MODEL 37081, LOT # NJB085780V.| IMPLANTED| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V584853028.| LEAD: MODEL 3778, LOT # V631663018.| PROGRAMMER: MODEL 37743, LOT # NKE158530N.| STIM ACCESSORY: MODEL 37092, LOT # 263630002.| PROGRAMMER: MODEL 37743, LOT # NKE158530N| IMPLANTED:| STIM ACCESSORY: MODEL 37092, LOT # 263630002| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED| EXTENSION: MODEL 37081, LOT # NJB085778V| EXPLANTED:| LEAD: MODEL 3778, LOT # V584853028| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB085780V| ACCESSORY: MODEL 37752, LOT # NKA150217N| LEAD: MODEL 3778, LOT # V631663018| IMPLANTED: