MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ALTRUA

Model Number S606

Device Problem Premature Discharge of Battery (1057)

Patient Problem Exit Block (2628)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, detailed mechanical and electrical testing was performed on the device.The device battery status was eri.The device functioned normally throughout testing.Laboratory analysis determined that this device experienced normal battery depletion; however, the estimated longevity remaining value appeared to decrease more quickly than expected between routine follow-ups.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any (even slight) changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please note that, despite the drop in estimated longevity remaining, the actual battery condition did not change significantly between follow-ups.In summary, it was determined that this device experienced normal battery depletion, but declared ert earlier than previously estimated.

Event Description

Boston scientific received information that this pacemaker battery depleted quicker than expected.Additional information stated the patient's pre-existing condition of third degree heart block did not influence the expected longevity.The pacemaker reached end of life (eol).Boston scientific technical services (ts) advised to replace the device as soon as possible.The pacemaker was explanted.No additional adverse patient effects were reported.

• Brand Name: ALTRUA
• 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: 7481349
• MDR Text Key: 107164671
• Report Number: 2124215-2018-07966
• Device Sequence Number: 1
• Product Code: LWP
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/27/2012
• Device Model Number: S606
• Other Device ID Number: ALTRUA 60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2010
• 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: 4469; 4471; S606
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 89 YR