BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2807088 · Received October 27, 2012

    Report

    Report Number
    3004209178-2012-09647
    Event Type
    Injury
    Date Received
    October 27, 2012
    Report Date
    September 28, 2012
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986A, LOT# N125489, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT# N140021, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD COUPLING AND COMMUNICATION ISSUES USING THE RECHARGER. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE DEVICES HAD BEEN OFF FOR ABOUT A YEAR. THE PATIENT'S PHYSICIAN PLANNED TO REPLACE THE DEVICES WITH NON-RECHARGEABLE DEVICE, HOWEVER NO SCHEDULED HAD BEEN SCHEDULED. ADDITIONAL INFORMATION RECEIVED REPORTED THE COUPLING ISSUES WERE DUE TO AN OVERDISCHARGE THAT WAS DUE TO PATIENT COMPLIANCE. THE BATTERY WAS REPLACED. PATIENT OUTCOME WAS NOTED AS NO INJURY. REFER TO MANUFACTURER REPORT# 3004209178-2012-09645.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT ON (B)(6) 2012, THE PATIENT STATED THAT SHE NEEDED HER GENERATORS REPLACED AND HAD COMPLAINED OF A PAINFUL RIGHT LEAD AND SHE WANTED THAT REVISED TOO. ON (B)(6) 2012 THE PATIENT WAS POST-OPERATION FOR GENERATOR REPLACEMENT AND RIGHT LEAD REVISION AND COMPLAINED OF CONTINUED TIGHTNESS IN THE RIGHT LEAD. THERE WAS A SIGNIFICANT RASH WHERE HER PREP WAS, THAT HAD IMPROVED SOMEWHAT. ON (B)(6) 2012, THE PATIENT MET WITH A COMPANY REPRESENTATIVE FOR PROGRAMMING. NO FURTHER INFORMATION ON THIS EVENT WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention