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

Model Number 5487

Device Problems No Device Output (1435); Material Integrity Problem (2978); Output Problem (3005)

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

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient cable was being used in conjunction with an external pulse generator (epg) on a patient post-operative.The patient¿s cardiac rhythm was driven by the epg system when there was a cessation of stimulation.The patient cable was replaced, and the issue was resolved.The status of the original patient cable is unknown.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Analysis was unable to confirm that the cable was the source of the customer experience that the external pulse generator had a cessation of stimulation.The cable passed all visual incoming inspection with no anomalies found and all continuity tests were ok with no intermittent or shorted connections found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the product had been returned to service.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8186053
• MDR Text Key: 131065349
• Report Number: 2182208-2018-02306
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5487
• Device Catalogue Number: 5487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention