BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3962100 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13620
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740 SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A160, SERIAL# (B)(4) IMPLANTED: (B)(6) 2014, PRODUCT TYPE; LEAD. PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED THEIR DEVICE ¿TUNED IN¿ BETTER. THE PATIENT HAD NEVER HAD THERAPEUTIC EFFECT. THE PATIENT ONLY HAD STIMULATION IN THEIR LEFT HAMSTRING AND LEFT BUTTOCKS AND NOT IN THEIR SPINE WHERE IT WAS SUPPOSED TO BE. THE PATIENT HAD THEIR DEVICE IMPLANTED ON (B)(6) 2014 AND THE STIMULATION ISSUE HAD BEEN PRESENT SINCE THE IMPLANT. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT HAVE A GREATER THAN 50% SYMPTOM REDUCTION. THE PATIENT HAD THEIR SPINAL CORD STIMULATOR (SCS) SYSTEM WAS SURGICALLY REVISED ON (B)(6) 2014 BUT THE ISSUES DID NOT RESOLVE. A REPROGRAMMING WAS DONE ON (B)(6) 2014. THE PATIENT HAD AN X-RAY OF THEIR SPINE. AFTER THE REPROGRAMMING THE PATIENT STILL CONTINUED TO HAVE MID AND LOW BACK PAIN THAT WAS NOT COVERED BY THEIR STIMULATOR. THE PATIENT WAS REFERRED TO A PAIN MANAGEMENT PHYSICIAN. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS LISTED AS ¿NOT RECOVERED, SYMPTOMS ONGOING¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438042 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention