BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3071226 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06662
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    May 16, 2011
    Report Date
    April 11, 2013
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED UNDESIRABLE STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THIS WAS POSSIBLY RELATED TO THE DEVICE THERAPY. THE PATIENT OUTCOME WAS REPORTED AS AN ON-GOING EVENT. ADDITIONAL INFORMATION REPORTED THAT UNDESIRABLE STIMULATION WAS POSSIBLY RELATED TO A MIGRATION OF THE LEAD COMPONENT. X-RAY RESULTS TAKEN ON (B)(6) 2011 SHOWED THAT THERE WAS NO CHANGE IN LEAD PLACEMENT. X-RAYS ALSO SHOWED THAT THE LEADS WERE AT THE LEVEL OF T9-T10 AND THAT THORACIC KYPHOSIS WAS SEEN. IT WAS REPORTED THAT THE UNDESIRABLE CHEST STIMULATION LASTED ABOUT 2 MONTHS BUT NOW ((B)(6) 2013) THE MAINS ISSUE WAS THAT THE PATIENT EXPERIENCED POOR PAIN COVERAGE FOR THEIR LOWER BACK AND INTERMITTENTLY FOR THEIR LEGS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE UNDESIRABLE STIMULATION (IN THE CHEST AREA) WAS CHANGED TO NOT RELATED TO LEAD MIGRATION. IT WAS NOTED THAT THE UNDESIRABLE STIMULATION LASTED ABOUT 2 MONTHS AND THAT THERE WAS IMPROVEMENT FOLLOWING A MOTOR VEHICLE ACCIDENT ON (B)(6) 2011. INTERVENTIONS PERFORMED WERE REPORTED AS REPROGRAMMING ON (B)(6) 2011 WITH AN IMPROVEMENT IN COVERAGE FOR THE PATIENT ON (B)(6) 2011. THE ETIOLOGY FOR THE EVENT WAS NOTED AS POSSIBLY RELATED THE INS THERAPY BUT UNLIKELY RELATED TO PROGRAMMING OR THE IMPLANT PROCEDURE. THE PATIENT OUTCOME, AS OF (B)(6) 2011, WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171367 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR