MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G158

Device Problems Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) patient presented to the emergency room due to muscle stimulation, and upon interrogation it was found that the device had three memory errors that put it into safety mode.There was limited function and unipolar sensing while in safety mode settings, which had caused oversensing with pacing inhibition and an inappropriate shock.There was no known radiation or other recent procedures.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.The device was returned for analysis.No additional adverse patient effects were reported.

Event Description

This report is being filed with analysis details.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety core, and review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.Device testing was performed, where normal device function was observed.The cause of the memory inconsistency was not able to be determined through laboratory testing, but was likely the result of exposure to radiation, either therapeutic or environmental.

• Brand Name: DYNAGEN X4 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
• MDR Report Key: 8778307
• MDR Text Key: 150629312
• Report Number: 2124215-2019-13494
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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: 03/09/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 167063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR