BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3953644 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13446
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    September 3, 2013
    Report Date
    January 29, 2020
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A290, LOT# 0207342368, IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A290, LOT# 0207380678, IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT BY CHANGING THE PROGRAMMING NO CHANGING ON THE PATIENT'S PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT INTERVENTION INCLUDED EXPLANTING AND REPLACING THE LEAD. THE PATIENT EXPERIENCED A LOSS OF STIMULATION AS A RESULT OF THE LEAD DISLODGEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT INTERVENTIONS INCLUDED EXPLANTING AND REPLACING THE LEAD. DIAGNOSTIC METHODS INCLUDED IMAGING WHICH SHOWED THAT THE LEAD MOVED. ON (B)(6) 2013 AN X-RAY WAS DONE AND THE RESULTS SEEMED GOOD, SO THEY TRIED A NEW PROGRAM BUT ON (B)(6) 2015, THE DOCTOR LOOKED CAREFULLY AT THE X-RAY DONE AND THE LEAD HAD MOVED SO THE PATIENT WAS PROGRAMMED AND THE LEAD WAS REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAD MIGRATION. IT WAS NOTED THAT ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED EXPLANT AND REPLACEMENT. IT WAS NOTED THAT THE DISLODGED LEAD WAS EXPLANTED AND REPLACED BY TWO NEW LEADS. IT WAS NOTED THAT THE IMPLANT PROCEDURE TOOK PLACE ON 2013 (B)(6). IT WAS NOTED THAT ON 2013 (B)(6), THE PATIENT REPORTED LEAD DISLODGEMENT. IT WAS NOTED THAT ON 2013 (B)(6) THE DISLODGED LEAD WAS EXPLANTED. IT WAS NOTED THAT THE EVENT WAS CONSIDERED RESOLVED. IT WAS NOTED THAT NO FURTHER INFORMATION WAS PROVIDED REGARDING CLINICAL DIAGNOSIS. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT FEEL STIMULATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON 2013 (B)(6) THE PATIENT DID NOT FEEL STIMULATION. IT WAS NOTED THAT ADJUSTMENTS WERE MADE AND IT WAS DECIDED TO CHANGE THE LEAD. IT WAS NOTED THAT FOLLOWING THE SYSTEM MEDICATION ON 2013 (B)(6) THE PATIENT STILL DID NOT FEEL STIMULATION. IT WAS NOTED THAT A SECOND SYSTEM MODIFICATION TOOK PLACE ON 2013 (B)(6) AT ANOTHER HOSPITAL. IT WAS NOTED THAT THE TWO LEADS WERE REPLACED BY A SURGICAL LEAD. IT WAS NOTED THAT FOLLOWING THE INTERVENTION THE PATIENT RECOVERED ON 2013 (B)(6) AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. IT WAS CORRECTED THAT THE NEW PROGRAM WAS TRIED ON (B)(6) 2013, NOT (B)(6) 2015 AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430122 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention