MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; PROGRAMMER, PACEMAKER

Model Number T177

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a review of device memory revealed that the device declared end of life (eol) after experiencing one charge time greater than 30 seconds.The observed rate of battery usage was compared to the expected rate of battery usage; the results indicated that the monitoring voltage was normal.Although the battery itself had not depleted prematurely, eol was triggered earlier than expected by extended charge times and the eri to eol time period was shortened due to a higher-than-typical build-up of internal battery impedance.The battery manufacturer introduced several manufacturing process improvements and controls designed to reduce variability in battery performance by minimizing the vanadium film formation that causes a mid-life impedance increase and longer charge times.Process improvements were implemented at three different times - late 2004, late 2005, and finally in 2007.Batteries with the 2007 improvements were used only in our confident and livian families of defibrillators, and have not exhibited this excessive increase of battery impedance during middle-life.A product update article describing this behavior in greater detail was communicated in (b)(6) 2006, and was updated most recently in (b)(6) 2007.Recent generations of boston scientific defibrillators use a completely different battery technology that does not experience a mid-life impedance increase.

Event Description

It was reported that this implantable cardioverter defibrillator exhibited long charge time and a code 01 which is indicative of charge timeout.The patient had gotten shocked two times.The first shock did not convert the patient, the second charge did.The patient had experienced a syncopal episode in which boston scientific technical services noted most likely happened the date of the shock.This device had hit end of life (eol) back in 2013 and was recently explanted for normal battery depletion.No adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator exhibited long charge time and a code 01 which is indicative of charge timeout.The patient had gotten shocked two times.The first shock did not convert the patient, the second charge did.The patient had experienced a syncopal episode in which boston scientific technical services noted most likely happened the date of the shock.This device had hit end of life (eol) back in 2013 and was recently explanted for normal battery depletion.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a review of device memory revealed that the device declared end of life (eol) after experiencing one charge time greater than 30 seconds.The observed rate of battery usage was compared to the expected rate of battery usage; the results indicated that the monitoring voltage was normal.Although the battery itself had not depleted prematurely, eol was triggered earlier than expected by extended charge times and the eri to eol time period was shortened due to a higher-than-typical build-up of internal battery impedance.The battery manufacturer introduced several manufacturing process improvements and controls designed to reduce variability in battery performance by minimizing the vanadium film formation that causes a mid-life impedance increase and longer charge times.Process improvements were implemented at three different times - late 2004, late 2005, and finally in 2007.Batteries with the 2007 improvements were used only in our confient and livian families of defibrillators, and have not exhibited this excessive increase of battery impedance during middle-life.A product update article describing this behavior in greater detail was communicated in (b)(6) 2006, and was updated most recently in (b)(6) 2007.Recent generations of boston scientific defibrillators use a completely different battery technology that does not experience a mid-life impedance increase.

• Type of Device: PROGRAMMER, PACEMAKER
• 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: 13262300
• MDR Text Key: 284310239
• Report Number: 2124215-2022-00551
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2008
• Device Model Number: T177
• Device Catalogue Number: T177
• Device Lot Number: 112416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1513-2008, Z-1514-2008
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male