BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1844584 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07224
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 23, 2010
    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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (B)(6), 2010 THAT THERE WAS NO STIMULATION SENSATION ON THE RIGHT SIDE, STIMULATION WAS ON THE LEFT SIDE. PT TRIED CHANGING GROUPS, INCREASING STIMULATION AND REPROGRAMMING. (B)(6), 2010, THE PT HAD SURGERY TO TRY TO REPOSITION THE LEAD THAT WAS TOO FAR TO THE LEFT. AFTER TRYING TO REMOVE THE ELECTRODE, THE DOCTOR DECIDED TO ADD A SUBCOMPACT PERCUTANEOUS LEAD ON THE RIGHT SIDE AFTER DISCONNECTING THE LEFT SIDE OF THE 2 X 8 LEAD. THE RIGHT SIDE OF THE 2 X 8 LEAD WAS EFFECTIVE FOR THE PT'S LEFT SIDE. PT REPORTS GOOD RELIEF AFTER PROGRAMMING POST IMPLANT #2.

    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 63 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB078467V| PROGRAMMER: MODEL 37743, LOT# NKE117660N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB078468V| LEAD: MODEL 39286-30, LOT# N222364001| EXPLANTED:| EXPLANTED: