BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 7734653 · Received July 31, 2018

    Report

    Report Number
    3004209178-2018-17008
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 27, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109506
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977C290, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 977C290 SERIAL(B)(6) IMPLANTED: (B)(6)2017 PRODUCT TYPE LEAD MEDTRONIC, INC. 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977C290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977C290 ,SERIAL# (B)(4), IMPLANTED: (B)(6) 2017. PRODUCT TYPE LEAD, PRODUCT ID 97792, SERIAL# UNKNOWN. PRODUCT TYPE ACCESSORY, PRODUCT ID 97792, SERIAL# UNKNOWN. PRODUCT TYPE ACCESSORY. ANALYSIS OF THE INS ((B)(4)) FOUND THE INS BATTERY CAPACITY REDUCED DUE TO OVERDISCHARGE. ANALYSIS OF LEAD ((B)(4)) FOUND ALL CONDUCTORS BROKEN AT THE INJEX ANCHOR SITE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE BATTERY DEPLETION HAD NOT BEEN DETERMINED, IT WAS UNKNOWN WHY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE BATTERY DEPLETION HAD NOT BEEN DETERMINED, IT WAS UNKNOWN WHY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE BATTERY DEPLETED AND IMPEDANCES WERE GREATER THAN 10,000. IT WAS UNKNOWN WHAT LED TO THE ISSUE. THE REP REPORTED THAT IMPEDANCES WERE READ WHEN THE SYSTEM WAS REPLACED. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579399 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712 00643169109506

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention