MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G173

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Telemetry Discrepancy (1629)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2019

Event Type  Injury  

Event Description

It was reported that this patient was admitted to hospital with a complete atrioventricular block (av block) and a substantial decrease in the battery longevity of this device was observed.The physicians were unable to interrogate this device and alleged the device battery had prematurely depleted.The physician elected to explant and replace this device to resolve the event and the patient was stable with no additional adverse consequences.The device is expected for analysis, but has not yet been received.

Event Description

It was reported that this patient was admitted to hospital with a complete atrioventricular block (av block) and a substantial decrease in the battery longevity of this device was observed.The physicians were unable to interrogate this device and alleged the device battery had prematurely depleted.The physician elected to explant and replace this device to resolve the event and the patient was stable with no additional adverse effects.The device was subsequently received for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed no anomalies.Collectively, the pattern of irregular daily battery voltage measurements in conjunction with normal power levels and device hybrid current draw is consistent with behavior of devices where a latent current leakage path has occurred within the battery itself, resulting in a partial depletion of the battery.A design enhancement was implemented in 2013 to enlarge the physical barrier between the battery's anode and cathode electrode layers to prevent current leakage.This device was manufactured with this enhancement, which was expected to improve but not completely eliminate this behavior.

• Brand Name: AUTOGEN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10653640
• MDR Text Key: 210571637
• Report Number: 2124215-2020-16955
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2016
• Device Model Number: G173
• Device Catalogue Number: G173
• Device Lot Number: 100922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 10/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR