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

Model Number S603

Device Problem Defective Device (2588)

Patient Problems Syncope (1610); Head Injury (1879); Injury (2348)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

This product has been returned for analysis.This report will be updated, upon analysis completion.

Event Description

Boston scientific received information that this patient was passing out about 1 time per week.The patient reportedly hit their arm and head, as a result.The sudden brady response (sbr) feature was reportedly very aggressive and nothing really worked for the patient.The physician was not happy with the sbr and decided to replace the patient's pacemaker with another manufacture's product.The patient has not passed out since they were implanted with the new device.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ALTRUA
• 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: 7727515
• MDR Text Key: 115270998
• Report Number: 2124215-2018-13705
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2010
• Device Model Number: S603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2008
• 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: 5076; MISMATCH; S603
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR