BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2420559 · Received January 18, 2012

    Report

    Report Number
    3004209178-2012-00342
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Report Date
    December 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ADAPTOR MODEL 3550-29 LOT# N221003 IMPLANTED (B)(6) 2009 EXPLANTED UNK; ADAPTOR MODEL 3550-29 LOT# N197001 IMPLANTED (B)(6) 2009 EXPLANTED UNK; EXTENSION MODEL 37083-20 SERIAL# (B)(4) IMPLANTED (B)(6) 2009 EXPLANTED UNK; EXTENSION MODEL 3708340 SERIAL# (B)(4); LEAD MODEL 3986A LOT# N111583 IMPLANTED (B)(6) 2009 EXPLANTED UNK; PROGRAMMER MODEL 37743 SERIAL# (B)(4); PROGRAMMER MODEL 37743 SERIAL# (B)(4); RECHARGER MODEL 37752 SERIAL# (B)(4); RECHARGER MODEL 37752 SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD SURGERY ON (B)(4) 2012. DETAILS OF THE SURGERY WERE NOT REPORTED. ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD THEIR LEAD REPLACED DURING THE REVISION ON (B)(6) 2012. THE PATIENT WAS HOSPITALIZED FOR THE SURGERY. THE PATIENT RECOVERED WITH NO SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD MIGRATED FOR THE SECOND TIME. THE PATIENT EXPERIENCED STIMULATION IN HER JAW, NECK, AND ARM INSTEAD OF IN HER FACE. THE PATIENT ALSO EXPERIENCED PAIN IN HER NECK WHICH HER PHYSICIAN STATED WAS DUE TO MOVEMENT OF THE CONNECTOR AT THE LEAD/EXTENSION CONNECTION SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD HAD MIGRATED DUE TO MOVING A REFRIGERATOR. AFTER THE REVISION, THE PATIENT WAS DISCHARGED. THE PATIENT WENT TO THE AIRPORT AND HAD RESPIRATORY FAILURE AND RETURNED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention