BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2850904 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10921
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF D11: PRODUCT ID 3998 LOT# V014190 SERIAL# IMPLANTED: 2008-07-11 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3998 LOT# V296379 SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 37743 LOT# SERIAL# NKE104345N IMPLANTED: 2008-07-11 EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708260 LOT# SERIAL# NKB004757V IMPLANTED: 2010-11-17 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 37082-40 LOT# SERIAL# NKB012569N IMPLANTED: 2008-07-11 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 355029 LOT# N104237 SERIAL# IMPLANTED: 2008-07-11 EXPLANTED: PRODUCT TYPE ACCESSORY F10.PATIENT CODES : C50476 C50541 DEVICE CODES : C63093 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PADDLE LEAD WAS IMPLANTED IN 2010 TO TREAT LOW BACK PAIN. AFTER THE LEAD WAS IMPLANTED, IT WAS REPORTED THAT THE PATIENT "REACHED TOO HIGH," WHICH RESULTED IN A SHOCKING AND BURNING SENSATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1