BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2172159 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04469
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 23, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AT THE POCKET SITE WHEN STIMULATION WAS ON. THE SHOCKING/JOLTING BEGAN AFTER THE PATIENT FELL. THE SHOCKING OCCURRED WHILE LYING DOWN, SITTING, AND/OR WALKING. UNKNOWN IF DEVICE TROUBLESHOOTING WAS PERFORMED. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. 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 PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3998, LOT# LB1627| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK016309V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK025057V| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154918N| ADAPTER: MODEL 74002, LOT# N240223| EXPLANTED:| IMPLANTED: