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

Model Number G156

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defibrillation/Stimulation Problem (1573); Unexpected Therapeutic Results (1631); Low impedance (2285); Delayed Charge Time (2586)

Patient Problems Cardiac Arrest (1762); Septic Shock (2068); No Code Available (3191)

Event Date 07/05/2020

Event Type  Injury  

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.(b)(4).

Event Description

It was reported that this patient went into cardiac arrest requiring cardiopulmonary resuscitation (cpr), external defibrillation and pacing and the placement of a temporary pacemaker.The patient was rescued and device interrogation was performed.A code 1004 indicating a shorted lead and code 1007 indicating the capacitor charge time has been exceeded were displayed.A review of the device data identified that battery capacity depleted (bcd) was declared and the device must be replaced.The device was explanted and returned for testing.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.External visual inspection identified no anomalies that would have contributed to the reported clinical observations.Review of device memory confirmed codes 1004 (indicative of a shorted shock lead) and 1007 (indicating a charge timeout) were recorded on (b)(6) 2020.The battery monitoring voltage was 3.07 volts confirming the end of life (eol) battery status had been set due to long charge times and not low battery voltage.An x-ray of the crt-d found the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted shock lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.As a result, the subsequent high voltage charge attempt caused the device to declare eol because it could not successfully complete charging within 30 seconds, despite the fact that significant battery voltage and capacity remained.Evidence indicates the associated rv lead was damaged and when this device attempted to deliver a shock through the lead, a short was detected.This device operated as designed in the presence of a shorted defibrillation lead.

Event Description

This supplemental report is being filed due to the completed evaluation of this product.

• 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: 10708559
• MDR Text Key: 212249115
• Report Number: 2124215-2020-21003
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2019
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 375217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 12/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 74 YR