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

Model Number 53912

Device Problem Connection Problem (2900)

Patient Problems Arrhythmia (1721); No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

The cable was in use for treatment.A review of the device history record could not be performed as the lot number of the cable is unknown.The cable in question was returned for analysis.Visual inspection found the cables to be intact.While checking the resistance of each connector it was found that there was no connection between the black connector and female mdt connector.After removing the strain relief it was found that the wire inside the solid grey cable had detached from the black connector at the solder joint and indicated there is a weak cable-to-connector solder joint.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.A follow-up report will be sent if additional information becomes available.A corrective and preventive action has been opened to address this issue.Mdr 1035166-2016-00014 addresses the second cable in this event.

Event Description

The customer reported there was over-sensing and over pacing when the tpm lead was inserted in the patient and connected to the external pulse generator (epg).Later there was undersensing of the qrs and pacing on t-wave, causing the patient to go into life threatening ventricular arrhythmia.The patient required cardioversion.Due to the problems reported, the facility checked the cables and identified two of the cables were problematic.During troubleshooting, the customer found that when the cable was moved after switching on the epg the sensing light flickerd even without external connection.The epg seemed to be functioning properly until the cables were moved.

Manufacturer Narrative

Type of reportable event: serious injury.

• Brand Name: MEDTRONIC REUSABLE EXTENSION CABLE
• Type of Device: ELECTRODE CABLE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer Contact: jan flegeau ; 3816 desoto blvd.; palm harbor, FL 34683-1618 ; 7279372511
• MDR Report Key: 5447908
• MDR Text Key: 39123574
• Report Number: 1035166-2016-00013
• Device Sequence Number: 1
• Product Code: IKD
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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