MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number D176

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 which is indicative of battery voltage too low for the projected remaining capacity.It was noted that the estimated remaining longevity decreased from six to one year in a three-month time period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected and device replacement was recommended.No adverse patient effects were reported.The device remains in service.Additional information was received.The patient attended the facility and upon device interrogation, it was found that it had entered safety mode.The device replacement procedure was scheduled, but at this time, there is no evidence to suggest that this intervention has been performed.No adverse patient effects were reported.The device remains in service.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 which is indicative of battery voltage too low for the projected remaining capacity.It was noted that the estimated remaining longevity decreased from six to one year in a three-month time period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected and device replacement was recommended.No adverse patient effects were reported.The device remains in service.Additional information was received.The patient attended the facility and upon device interrogation, it was found that it had entered safety mode.The device replacement procedure was scheduled, but at this time, there is no evidence to suggest that this intervention has been performed.No adverse patient effects were reported.The device remains in service.Additional information provided from the field indicated surgical intervention was later performed and this device was explanted and replaced.No additional adverse patient effects were reported.The device is expected to be returned for analysis.

• Brand Name: AUTOGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 18969442
• MDR Text Key: 338498973
• Report Number: 2124215-2024-17830
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: D176
• Device Catalogue Number: D176
• Device Lot Number: 507231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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
• Patient Age: 81 YR