MAUDE Adverse Event Report: MEDTRONIC, INC.; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 5487

Device Problems Connection Problem (2900); Output Problem (3005)

Patient Problem Cardiac Arrest (1762)

Event Date 10/20/2016

Event Type  Injury  

Event Description

It was reported before coronary artery bypass surgery, a cable had been placed and plugged in to an external pacemaker.During the procedure, the product showed a dysfunction which caused the patient cardiac arrest.It had been replaced by another of the same lot which presented the same default.The plug between electrodes and wire connection seemed to be deficient.When the connection was moved, sometimes it worked again.During this, the patient received an internal heart massage.Finally the cable was replaced by a different model cable.The cables were returned for analysis.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: manufacturer's analysis was unable to confirm the customer comments regarding the cable.During analysis the cable passed all visual incoming inspection with no anomalies found, and the cable passed all continuity tests with no intermittent or shorted connections found.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6163053
• MDR Text Key: 62086720
• Report Number: 2182208-2016-02799
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K960446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2018
• Device Model Number: 5487
• Device Catalogue Number: 5487
• Device Lot Number: 553060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention