BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2102347 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-03690
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION FOLLOWING A POSITION CHANGE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 H0109321

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC008525N| EXTENSION: MODEL 37083, LOT# NKC008985N| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0437298V| LEAD: MODEL 3888, LOT# L39705| PROGRAMMER: MODEL 37742, LOT# NJD024868N| RECHARGER: MODEL 37752, LOT# NKA019629N| RECHARGER: MODEL 37752, LOT# NKA019629N| LEAD: MODEL 3487A, LOT# J0437298V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC008525N| PROGRAMMER: MODEL 37742, LOT# NJD024868N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC008985N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# L39705| EXPLANTED:| IMPLANTED: