BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 7091234 · Received December 7, 2017

    Report

    Report Number
    2182208-2017-01918
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    January 1, 2017
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. OF NOTE, THE INFORMATION WAS GARNERED FROM THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. POSSIBLE MODELS FOR THIS MANUFACTURER COULD INCLUDE: SENSIA DR, SENSIA D, RELIA DR, RELIA D, AND ADAPTA. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: FREQUENCY OF PACEMAKER MALFUNCTION ASSOCIATED WITH MONOPOLAR ELECTROSURGERY DURING PULSE GENERATOR REPLACEMENT OR UPGRADE SURGERY J INTERV CARD ELECTROPHYSIOL (2017) 49:205¿209. DOI 10.1007/S10840-017-0241-Y. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED SUBSEQUENT FOLLOW UP INFORMATION OBTAINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPGS). THE AIM OF THE ARTICLE/STUDY WAS TO ¿INVESTIGATE THE FREQUENCY OF ELECTROSURGERY-RELATED PACEMAKER MALFUNCTION.¿ MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. OF NOTE, THE INFORMATION WAS GARNERED FROM THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. THE ARTICLE REPORTED THERE WERE DEVICE MALFUNCTIONS WHICH RESULTED IN EXPLANTS AND REPLACEMENTS. THERE WERE ALSO DEVICE UPGRADE PROCEDURES. THE AUTHOR INDICATED THAT THE MALFUNCTIONS COULD BE FROM PREMATURE ELECTIVE REPLACEMENT INDICATOR (ERI), FAILURE TO INTERROGATE, LOSS OF CAPTURE, THRESHOLDS/IMPEDANCE ¿ISSUES,¿ AND DEVICES REMOVED DUE TO INFECTION. THE STATUS/LOCATION OF THE DEVICE IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW UP INDICATED THAT THE CUSTOMER WOULD NOT BE ANSWERING THE FOLLOW UP QUESTIONS. NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872415 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R IMPLANTABLE PACING LEAD