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

Model Number 53912

Device Problem Connection Problem (2900)

Patient Problem Complete Heart Block (2627)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

The device was in use for treatment.The device was returned to medtronic for a functionality test; their analysis found the extension cable to be broken, and the pacemaker to work as per specification.Since the lot number of the extension cable was not provided, a review of the device history record could not be performed.Review of the atar cable inspection procedure identified that inspection of the following is done per 100 percent: 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 percent 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 Description

The customer reported that after interrogation of the pacemaker, the patient went in complete av block and started to convulse as the device stopped pacing.External cardiac massage was immediately started and the patient was brought to the catheterization lab.A temporary pacing lead was implanted and connected to the external pacer and extension cable.Following connection of the external pacer and extension cable to the temporary pacing lead, no pacing occured.The pacing lead was then connected to another external pacer brand and it functioned.

Manufacturer Narrative

This device was not reprocessed or reused on a patient.The information reported in the original mdr report was entered in error.

• 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: 5676763
• MDR Text Key: 45827687
• Report Number: 1035166-2016-00096
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention