BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3113468 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07684
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 24, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE TODAY. IT WAS STATED THAT THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) SINCE 2007 AND ALL HAD BEEN WELL. IT WAS NOTED THAT THE PATIENT HAD LOST 107 POUNDS AND OVER THE LAST TWO WEEKS, THE STIMULATION ON THE LEFT SIDE HAD SHIFTED TO HER STOMACH AND GROIN. REPROGRAMMING WAS PERFORMED WITHOUT SUCCESS. THERE WAS NO KNOWN TRAUMA OR FALL ASSOCIATED WITH CAUSING THE LEAD TO SHIFT, BUT THE INS REPORTEDLY "TWISTS AND FLOPS" IN THE POCKET. THE HEALTHCARE PROVIDER (HCP) WAS CONSULTED AND A LEAD REVISION/INS REPLACEMENT (SINCE INS WAS 5+ YEARS OLD) WAS DEEMED NECESSARY. IT WAS LATER REPORTED THAT THE INS WAS "LOOSE" IN THE POCKET (RIGHT BUTTOCK). THE LEADS WERE CHECKED AND THE IMPEDANCES WERE FOUND TO BE WITHIN NORMAL LIMITS. IT WAS STATED THAT ONE LEAD COVERED ALL OF THE "PAINFUL AREA" AND THE OTHER LEAD STIMULATED THE RIBS AND BELLY. IT WAS ADDED THAT THERE WAS NO PLAN TO REVISE THE LEADS. THE INS POCKET WAS MOVED, THE INS WAS REPLACED, AND EXTENSIONS WERE ADDED. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS STATED THERE WAS A LOSS OF STIMULATION/LOSS OF THERAPEUTIC EFFECT AND LESS THAN 50% THERAPY RELIEF. IT WAS LATER REPORTED THERE WAS PAIN AT THE DEVICE POCKET AND "RIGHT SIDE IMPLANT." THE PATIENT WAS REPORTED AS ALIVE WITH NO INJURY/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214088 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention