MAUDE Adverse Event Report: BOSTON SCIENTIFIC; IMPLANTABLE LEAD

Device Problems Device Alarm System (1012); Impedance Problem (2950)

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

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

At this time, the product remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that the implantable cardioverter defibrillator (icd), connected to this lead, was beeping.It was determined that the icd triggered an alert for an out of range shock impedance measurement.The field representative reported that the issue is resolved and that the serial number of the system was not known.No adverse patient effects were reported.

• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC
• Manufacturer Contact: timothy degroot ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515826168
• MDR Report Key: 7488057
• MDR Text Key: 107482171
• Report Number: 2124215-2018-08169
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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