BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7650080 · Received June 29, 2018

    Report

    Report Number
    3004209178-2018-14638
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 8, 2018
    Report Date
    August 14, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID 3777-60 LOT# SERIAL# (B)(4) PRODUCT TYPE LEAD PRODUCT ID 3777-60 LOT# SERIAL# (B)(4) PRODUCT TYPE LEAD PRODUCT ID 97715 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2018 PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR SUPPLEMENTAL TO UPDATE H.6 CODES, CODE 11, 3221 NO LONGER APPLIES, THE CODES 213, 825 AND 4310 APPLY TO THE IMPLANTABLE NEUROSTIMULATOR (SERIAL NUMBER (B)(4) WHILE THE CODES 122, 452 AND 4315 APPLY TO THE ELECTRICAL LEAD (SERIAL NUMBER (B)(4) H3: ANALYSIS OF THE ELECTRICAL LEAD (SERIAL NUMBER (B)(4) FOUND THAT THE LEAD BODY CONDUCTOR WAS BROKEN AND THE ANCHOR SITE WAS UNKNOWN. 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 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO HAD AN IMPLANTABLE NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THERE WERE A COUPLE OF ELECTRODES THAT WERE OUT OF RANGE. WHEN IMPEDANCE VALUES WERE RAN AT 80HZ, 210PW, 3.2V AND XXX (500), IT READ 9-10 DAYS RECHARGE INTERVAL FOR CALCULATION. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493753 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR