BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1840060 · Received September 15, 2010

    Report

    Report Number
    3004209178-2010-06993
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    March 1, 2010
    Report Date
    August 16, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3487A LOT# V284055 IMPLANTED: 2009-(B)(6) EXPLANTED: 2010-(B)(6); LEAD MODEL 3487A LOT# V284055 IMPLANTED: 2009-(B)(6) EXPLANTED: 2010-(B)(6); LEAD MODEL 3776-60 SERIAL# (B)(4) IMPLANTED: 2009-(B)(6) EXPLANTED: 2010-(B)(6); EXTENSION MODEL 37082 SERIAL# (B)(4) IMPLANTED: 2009-(B)(6) EXPLANTED: 2010-(B)(6); ANCHOR MODEL 3550-39 LOT# N218869 IMPLANTED: 2009-(B)(6) EXPLANTED: 2010-(B)(6); ANCHOR MODEL 3550-39 LOT# N210962 IMPLANTED: 2009-(B)(6) EXPLANTED: 2010-(B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD UNDERGONE THREE SURGERIES TO MOVE THE LEAD TO WORK IN HIS LOWER LEGS. THE MANUFACTURER'S DEVICE REGISTRY CONFIRMED THAT THE PATIENT'S LEADS HAD BEEN EXPLANTED AND REPLACED WITH A PADDLE LEAD. FOR SUBSEQUENT EVENTS, SEE MFR. REP. # 3004209178-2012-04120.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STIMULATION "FLUCTUATED" WHEN THE PATIENT MOVED SO HE HAD TO ADJUST STIMULATION OF TEN, AND THAT HAD BEEN GOING ON SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT WAS ABLE TO TURN STIMULATION ON LAST NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# N218869| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB011782N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE133603N| IMPLANTED:| LEAD: MODEL 3487A, LOT# V284055| ACCESSORY: MODEL 37752, LOT# NKA132654N| LEAD: MODEL 3487A, LOT# V284055| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 207350001| STIM ACCESSORY: MODEL 3550-39, LOT# N210962| EXPLANTED:| LEAD: MODEL 3776, LOT# V190107034