MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 86 CM LV LEAD; DEFIB, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION (CRT-D)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/13/2019

Event Type  malfunction  

Event Description

Failure of st jude medical 86 cm lv lead; medtronic lv lead obtained and utilized in case successfully.There was no known patient harm.

• Brand Name: 86 CM LV LEAD
• Type of Device: DEFIB, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION (CRT-D)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9699835
• MDR Text Key: 178778207
• Report Number: 9699835
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2019,08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1