MAUDE Adverse Event Report: OSCOR INC. MEDTRONIC REUSABLE EXTENSION CABLE; CABLE, ELECTRODE

Model Number	53912
Medical Device Problem Codes	Break (1069); Capturing Problem (2891); No Pacing (3268)
Health Effect - Clinical Code	Diminished Pulse Pressure (2606)
Date of Event	07/02/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is part of an internal retrospective review of complaints, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained.As part of the detailed review, this event has been determined to be reportable.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported that while a patient was connected to a external pulse generator (epg), non-capture was noted on the monitor.Output was increased to the maximum setting with no capture.The batteries in the epg were changed and intermittent pacing was noted with manipulation of the cable.The epg was changed out for a different one and capture was noted with return of pulse and blood pressure.Upon examination of the epg extension cable, it was noted that the cable was broken beneath the connection on the proximal black pin.The patient status returned to stable condition after resumption of pacing.No further patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC REUSABLE EXTENSION CABLE
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6437717
• Report Number: 1035166-2017-00028
• Device Sequence Number: 18840621
• Product Code: IKD
• UDI-Device Identifier: 00885672101930
• UDI-Public: 00885672101930
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5391 EXTERNAL PACE GENERATOR, SERIAL NUMBER (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention