BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1864492 · Received October 6, 2010

    Report

    Report Number
    3004209178-2010-07646
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    August 1, 2010
    Report Date
    December 28, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN BELIEVED, A PATIENT BECAME INFECTED AFTER A SPINAL CORD STIMULATOR WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention "SEE H10...."| ACCESSORY: MODEL 37752, LOT# NKA139464N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB001630V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V442620021| LEAD: MODEL 3998, LOT# V415288| PROGRAMMER: MODEL 37743, LOT# NKE148861N| STIM ACCESSORY: MODEL 3550-39, LOT# N248244| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# V415288| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB001630V| IMPLANTED:| EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# N248244| EXPLANTED:| LEAD: MODEL 3777, LOT# V442620021| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE148861N| ACCESSORY: MODEL 37752, LOT# NKA139464N