BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5545702 · Received April 4, 2016

    Report

    Report Number
    3004209178-2016-06007
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    January 31, 2016
    Report Date
    April 4, 2016
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE THAT INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD .SEE ALSO MFG. REPORT NO. 3004209178-2016-01345.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT STIMULATION WAS FELT AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE (LEFT ABDOMEN) WHILE WORKING NEAR COMMERCIAL AND INDUSTRIAL FACILITY EQUIPMENT. USUALLY THE CONSUMER TURNS THE STIMULATION OFF WHILE DOING WORK; HOWEVER, IT WAS SET TO ON BY CHANCE "AT INCIDENT OF THE MALFUNCTION" AND THUS THE CONSUMER REALIZED THE FEELING OF STIMULATION. ACTIONS/INTERVENTIONS WERE NOTED AS THE CONSUMER WAS TURNING THE INS OFF DURING WORKING HOURS AS THE PAIN WAS NOT AGGRAVATED/WORSENED AND THERE WAS NO ISSUE WITH DOING SO. NO FURTHER ACTION TO BE TAKEN. DEVICE SETTINGS WERE AS FOLLOWS: AMPLITUDE (V): 1CH:6.6, 2CH:3.1; PULSE WIDTH (US)): 1CH:360, 2CH:390; IMPEDANCE (OHM): 1,000 OHMS; RATE (HZ/PPS): 2; POLARITY (UNI OR BI): BIPOLAR; ELECTRODE# FOR ANODE: 1CH:9, 2CH:10; ELECTRODE# FOR CATHODE: 1CH:1/11, 2CH:2; USAGE (HRS/DAY): 18HRS/DAY. THE CONSUMER'S MEDICAL HISTORY INCLUDED POSTHERPETIC PAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201129 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR