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

Model Number 53912

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is part of 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.The cable was not returned for analysis, and it was reported no patient complications have been reported as a result of this event.A review of the device history record for this cable could not be performed as the lot number is unknown.Since the cable was not returned for analysis, the root cause of the cable failure could not be confirmed.The potential cause may be: insufficient strength of the joint.The potential effect to the user/device may be: disruption of the cable function, cable cannot be used properly, and delaying the procedure.Based on this investigation a capa has been opened to address this failure.Oscor will continue to monitor this device for complaint trends and risk.Per cable inspection procedure during in process inspection, the cable is inspected 100% for continuity.During final inspection, each strand of the cable is checked for the correct colored part, overall length of the cable, cable checked for damage and insulation voids, verification that the silicone strain relief extends at least for a length of 2 cm outside the female connector, checked that the silicone strain relief fits the wire snugly, checks for strain relieves for damage and gaps, a pull test is done on each connector and pin, and the cable is inspected again for continuity.The instructions for use (ifu) informs the user: for reusable cables only: the cables can be re-sterilized by oscor eto gas sterilization a maximum of two times.The directions for use inform the user to: first attach the proximal connector(s) to a pacemaker/analyzer or another extension cable while observing polarity indicated by the color.Then attach the distal connector(s) to the temporary lead connector or to another extension cable, again observing polarity by the color.The detachment of the connection should be done in the reverse order.Precautions include: do not connect any cable model to a/c power source; connection of exposed pins to a/c power source may pose a risk of serious injury or death.Extension cables are not intended for use with apnea monitors.

Event Description

It was reported that the external pulse generator (epg) would not capture due to a cable losing connection.Another epg was used to provide therapy.The cable was replaced and the epg remains in use.No patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC REUSABLE EXTENSION CABLE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 6604581
• MDR Text Key: 76421266
• Report Number: 1035166-2017-00041
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00885672101930
• UDI-Public: 00885672101930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXTERNAL PULSE GENERATOR