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

Model Number S501

Device Problems Premature Discharge of Battery (1057); High Capture Threshold (3266)

Patient Problem Injury (2348)

Event Date 01/26/2019

Event Type  Injury  

Manufacturer Narrative

This device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that during a routine follow up appointment, this pacemaker was found to be operating in automatic capture retry mode.An electrocardiogram revealed the patient was in chronic atrial fibrillation (af) with an occasional paced beat at 50 bpm.In august 2018, this pacemaker had an estimated longevity of two years but declared end of life (eol) in may.It is unknown if the rapid battery depletion was due to a lead issue/automatic capture retry or premature battery depletion (pbd).The device was explanted and discarded.

• 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8818727
• MDR Text Key: 151953278
• Report Number: 2124215-2019-14290
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2012
• Device Model Number: S501
• Device Catalogue Number: S501
• Device Lot Number: 576980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR