MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INSIGNIA; IMPLANTABLE PULSE GENERATOR

Model Number 1198

Device Problems Connection Problem (2900); Device Contamination With Biological Material (2908)

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

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that, in (b)(6) 2018, this patient presented for a routine generator change-out of this pacemaker.During the revision, a competitor wrench was used to loosen the set-screws of the device.One of the set-screws would not loosen and two wrenches were broken during attempts.The physician made the decision to abandon the system on the left side and implant a new system on the right.A few months later, a second procedure was performed to remove the abandoned system.The physician noted during this procedure that a significant amount of blood was in the device header.The competitors right ventricular lead was cut in order to remove the device.This pacemaker was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, inspection confirmed that the ring setscrew seal plug had lifted allowing body fluid to enter the header.The cause of this issue was isolated to inadequate seal plug adhesion.

• Brand Name: INSIGNIA
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7619493
• MDR Text Key: 111671671
• Report Number: 2124215-2018-10219
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/04/2009
• Device Model Number: 1198
• Other Device ID Number: INSIGNIA I ENTRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2007
• 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: 1198; 5076
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention