BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5016018 · Received August 19, 2015

    Report

    Report Number
    3004209178-2015-16324
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    May 19, 2015
    Report Date
    March 14, 2017
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE PATIENT FELL AND HAD LESS BACK COVERAGE. THE EVENT WAS NOT SERIOUS. NO DIAGNOSTIC TESTS WERE PERFORMED. THE EVENT WAS NOTED AS NOT RELATED TO THE DEVICE, THERAPY, OR IMPLANT PROCEDURE. THE ETIOLOGY WAS PRE-EXISTING CONDITION (WORSENING IN FREQUENCY, INTENSITY, OR DURATION OVER WHAT WAS REPORTED AS BASELINE.) NO INTERVENTIONS WERE PERFORMED. THE OUTCOME WAS REPORTED AS RESOLVED WITH SEQUELAE. THE SEQUELAE WAS NOTED AS "ALTERED IMPLANT STIMULATION."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE PATIENT HAD A HISTORY OF FALLING WHILE AMBULATING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. SEQUELA WAS NOTED AS PROGRAMMING UNRELATED TO FALL. THE PATIENT HAD A HISTORY OF FALLING WHILE AMBULATING.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE PATIENT EXPERIENCED A FALL. SIGNS AND SYMPTOMS INCLUDED THAT THE PATIENT HAD LESS BACK COVERAGE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. RELEVANT MEDICAL HISTORY INCLUDED: NON-MALIGNANT PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550206 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR