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

Model Number G151

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); High Capture Threshold (3266)

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

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) has depleted from 11 months and during the recent checked it was less than 3 months battery remaining.Boston scientific technical services (ts) discussed that the battery will take 30 days to get an accurate longevity remaining and the output adjustments have been frequent.Data analysis showed that basing on the most recent settings, the power consumption would be 270 micro watts and would have about 62 days of capacity to explant or elective replacement indicator (eri).As of this time, this device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Correction to field f10: device codes, h6: device codes, and h1: type of reportable event.This supplemental correction report was created to capture the additional information received which indicates that there were no issues on the device and no actions taken.This observation no longer meets the definition of malfunction as it was confirmed that the device was operating normally.Amending mdr decision to mdr=no report.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) has depleted from 11 months and during the recent checked it was less than 3 months battery remaining.Moreover, outputs have been adjusted for elevated thresholds.Boston scientific technical services (ts) discussed that the battery will take 30 days to get an accurate longevity remaining and the output adjustments have been frequent.Data analysis showed that basing on the most recent settings, the power consumption would be 270 micro watts and would have about 62 days of capacity to explant or elective replacement indicator (eri).As of this time, this device remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 17389384
• MDR Text Key: 319844880
• Report Number: 2124215-2023-39280
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2021
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 131143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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 Age: 74 YR
• Patient Sex: Male