BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3903242 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12301
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-29, LOT# N432423, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3887-33, LOT# J0320137V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES WERE OUT OF RANGE. IT WAS NOTED THAT THE OUTCOME WAS ONGOING. IT WAS NOTED THAT INTERVENTIONS INCLUDED THAT THE EXTENSION WAS REPLACED ON (B)(6) 2014. IT WAS NOTED THAT DIAGNOSTICS INCLUDED DEVICE INTERROGATION. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND RELATED TO THE IMPLANT PROCEDURE. IT WAS NOTED THAT IMPEDANCES WERE OUT OF RANGE AT IMPEDANCE CHECK AFTER IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. IT WAS NOTED THAT THE EXTENSION WAS REPLACED AND WERE STILL OUT OF RANGE. IT WAS NOTED THAT THE SPINAL CORD STIMULATOR (SCS) WAS WORKING WELL FOR THE PATIENT SO THE DECISION WAS NOT TO REPLACE LEADS AT THIS TIME. IT WAS NOTED THAT IT WOULD BE RECHECKED AT INITIATION OR THERAPY VISIT. IT WAS NOTED THAT THE SEVERITY WAS MILD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES WERE HIGH. IT WAS REPORTED THAT ACTION WAS NOT TAKEN YET BUT WAS PLANNING. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED INDICATING THAT THERE WERE HIGH IMPEDANCES AT IMPEDANCE CHECK AFTER INS REPLACEMENT. THE EXTENSIONS WERE REPLACED AND IMPEDANCES REMAINED HIGH. THE INITIAL PROGRAMMING WAS UNSUCCESSFUL. OLD LEAD REPLACED WITH IMPEDANCES WITHIN NORMAL LIMITS AND INITIAL PROGRAMMING SUCCESSFUL. HIGH IMPEDANCES WERE REPORTED ON (B)(6) 2014 AND AGAIN WHILE REPROGRAMMING THE ENTIRE SYSTEM ON (B)(6) 2014. INITIAL PROGRAMMING WAS UNSUCCESSFUL FOLLOWING EXTENSION REPLACEMENT. ON (B)(6) 2014 THE OLD LEAD WAS EXPLANTED AND IMPLANTED TWO NEW LEADS. THE REPROGRAMMING ON (B)(6) 2014 LED TO SUCCESSFUL PROGRAMMING AND THE PATIENT HAVING GREAT COVERAGE. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. ADDITIONAL INFORMATION WAS REPORTED INDICATED THAT THE INITIAL PROGRAMMING POST-IMPLANT WAS UNSUCCESSFUL AND THAT THE INITIAL LEAD REPLACED WITH IMPEDANCES WAS WITHIN NORMAL LIMITS AND SUCCESSFUL PROGRAMMING AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380637 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention