BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1872430 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07798
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    March 1, 2010
    Report Date
    August 17, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A PROBLEM WITH HER NEUROSTIMULATOR. THE PT FELL ON HER IMPLANTABLE NEUROSTIMULATOR IN (B)(6) 2010 AND THEN FELT "A SHOCKING OR JOLTING SENSATION" IN HER "BACK REGION." A COMPANY REPRESENTATIVE CHECKED THE IMPEDANCES OF THE DEVICE AND ALL WERE NORMAL. AN X-RAY WAS TAKEN AND "DID NOT VISIBLY SHOW ANY ISSUE WITH IMPLANT." THE DEVICE WAS REPROGRAMMED, BUT THE PT STILL FELT "SHOCKING AND SOME SLIGHT PAIN" AT THE NEUROSTIMULATOR POCKET SITE. ADDITIONAL INFO HAS BEEN REPEATED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V341066031| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132779N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136083N| LEAD: MODEL 3778, LOT# V341066029