MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL PATIENT CABLE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 401695

Device Problems Material Separation (1562); Loss of Threshold (1633)

Patient Problem Bradycardia (1751)

Event Date 08/16/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Following the procedure, after implant of a temporary pacemaker, the patient developed bradycardia and momentarily passed out due no pacing from the pacemaker.The thumbscrew was attempted to be tightened, but the terminal pin was unable to be locked with the thumbscrew of the cable and the pin came out when soft tension was put on the catheter.The connector was reattached to the patient cable and the connection was fixed with gauze and a permanent pacemaker was implanted into the patient on (b)(6) 2020.The patient left the hospital on (b)(6) 2020 with no adverse patient consequences.

Manufacturer Narrative

One pacel patient cable was received for evaluation.The (¿-¿) negative connector was examined under magnification.There was solder present at the bottom of the connector.It was also noted that there was solder on the inner wall of the connector.There should not be any solder in this area of the connector.It is possible that initially the solder protruded further into the inner diameter (i.D.) of the connector causing interference with fully inserting/securing the connector pin.After multiple insertions during this investigation, the solder was worn away, and no additional resistance was felt.Cause of connection issue is solder within connector.

• Brand Name: PACEL PATIENT CABLE
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 10533934
• MDR Text Key: 206944147
• Report Number: 2182269-2020-00077
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 401695
• Device Lot Number: 7247918
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention