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

Model Number 53912

Device Problem Connection Problem (2900)

Patient Problems Fainting (1847); No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.A review of the device history records could not be performed as the lot number of the device is unknown.No conclusions can be drawn.Additional information has been requested but not provided.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.

Event Description

The customer reported that the cable that goes to one of the red/black connectors which are connected to the external pulse generator (epg) has broken and detached from the connector.The patient experienced dizziness and the doctor noticed that there were no pacing spikes.They changed the epg to solve the issue.

• 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: 5448948
• MDR Text Key: 38647738
• Report Number: 1035166-2016-00020
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2016

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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• 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