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

Model Number	53912
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is part of internal retrospective review of complaints received from march 2014 to march 2016, 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.A review of the device history record (dhr) could not be performed as the lot number of the cable was not provided.As the device was not returned, however, the cause of the cable failure is determined to be a weak cable-to-connector solder joint.The potential cause of this failure may be: insufficient strength of soldering and crimping of connectors to the cable wire.The potential effect to the user/device may be: disruption of the cable function.A corrective and preventive action has been opened to address this failure.Oscor will continue to monitor this device for complaint trends and risk.Review of the atar mdts cable inspection procedure identified that inspection of the following is done per 100%: each strand of the cable is checked for the correct colored part, cable is measured and verified for overall length, cable is checked for damage and insulation voids, the inspector verifies that the silicone strain relief extends at least for a length of 2 cm outside the female connector, the silicone strain relief is checked so that it fits the wire snugly, strain relieves are checked for damage and gaps, and pull test to verify strength of soldered joint.The cable is also 100% inspected for continuity and for proper connector function.The instructions for use (ifu) informs the user that the cable can be re-sterilized by oscor eto gas sterilization a maximum of two times.Precautions are provided to the user: 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.
Event or Problem Description
It was reported that while the patient was using a single chamber external pulse generator (epg) the nurse lifted the device cot-side and broke the temporary pacemaker cable.Only the cable was returned to the manufacturer.No patient complications were 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: 6389216
• Report Number: 1035166-2017-00020
• Device Sequence Number: 19027650
• 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,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 03/08/2017
• 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 PULSE GENERATOR