MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problem Difficult to Insert (1316)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that during the initial implant procedure, several attempts failed to fix the lead in the left ventricle.The lead was not used and physician attempted to implant another lead.However, the second lead could not be fixed either.When physician intended to implant a third lead, the patient¿s blood pressure dropped and the procedure was ended without implanting any lead.Malfunction on both of the leads was suspected.The patient is currently stable.

Manufacturer Narrative

Final analysis revealed a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.The s-curve hump height was measured within specification.The connector pin was found pulled away from the connector assembly.The inner coil was noted stretched with a stylet inserted.The polytetrafluoroethylene (ptfe) coating was stripped from the stylet with inner coil bunching consistent with procedural damage.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7849381
• MDR Text Key: 119337453
• Report Number: 2938836-2018-10409
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 1458Q/86
• Device Lot Number: A000047161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 09/07/2018; 10/19/2018
• Supplement Dates FDA Received: 09/17/2018; 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1642T/52, (B)(4)
• Patient Age: 72 YR
• Patient Weight: 65