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

Model Number 5487L

Device Problems Intermittent Capture (1080); Failure to Capture (1081); Loose or Intermittent Connection (1371)

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

Event Date 05/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that while in use the external pulse generator lost capture and it was attributed to a loose connection between the lead and the generator.The temporary external pulse generator was replaced by a permanent pulse generator.Following the loss of capture it was noted that the patient had to be externally paced.The lead (cable) is expected to be returned.It was noted that the patient was alive with no injury and no further patient complication have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis did not confirm the customer comment of loose connection, the cable passed its visual inspection with no anomalies found and all continuity tests were okay.No intermittent or shorted connections were found and the connector held the cable firmly.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: 7557725
• MDR Text Key: 109686210
• Report Number: 2182208-2018-01005
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 20643169307357
• UDI-Public: 20643169307357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5487L
• Device Catalogue Number: 5487L
• Device Lot Number: 647460001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2018
• 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
• Treatment: EPG,
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 55 YR