MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 50; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number S502

Device Problems Premature Discharge of Battery (1057); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

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 (ert) expected replacement time.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

It was reported during on going use, the device was showing premature battery depletion.The device was explanted and replaced on (b)(6) 2019.No adverse patient effects were reported.

• Brand Name: ALTRUA 50
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9570516
• MDR Text Key: 174362127
• Report Number: 2124215-2019-27670
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/13/2015
• Device Model Number: S502
• Device Catalogue Number: S502
• Device Lot Number: 727726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention