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

Model Number S603

Device Problems Premature Discharge of Battery (1057); Migration or Expulsion of Device (1395); Under-Sensing (1661); Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Records indicate this device and lead remain in service.This report will be updated should additional information become available.

Event Description

Boston scientific received information that this pacemaker and right atrial (ra) lead exhibited an increase in pacing threshold measurements.Additionally, a decrease in p-wave measurements was noted along with some atrial undersensing.The outputs were increased due to the rise in threshold measurements.At a recent device check the remaining longevity was displayed as less than.5 years.There was a concern the battery was depleting prematurely.Data was sent for review and it was noted the device had reached elective replacement indicator (eri).Boston scientific technical services (ts) discussed the device would have 90 days before reaching end of life (eol).It was noted an x-ray was performed which showed the device may have migrated resulting in an altered ra lead position.Lead replacement was being considered when device replacement takes place.No adverse patient effects were reported.

• 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: 7615252
• MDR Text Key: 111652100
• Report Number: 2124215-2018-08489
• 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: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

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: Lay User/Patient
• Device Expiration Date: 02/25/2014
• Device Model Number: S603
• Other Device ID Number: ALTRUA 60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2012
• 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