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

Model Number 53912

Device Problem Connection Problem (2900)

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

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.The cable was discarded by the facility; and therefore, cannot be returned for analysis.A review of the device history record could not be performed as the lot number of the device is unknown.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 after several manipulations of this adapter by the nurses, the outer sheath breaks and the internal wire is seen.As a result there is intermittent pacing.There was no report of any adverse patient effects from this event.

• 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: 5447995
• MDR Text Key: 38645439
• Report Number: 1035166-2016-00022
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Nurse
• 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