MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE DEVICE

Model Number G151

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130); No Code Available (3191)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) declared code 1005, which indicates an open circuit was detected during shock delivery.Several unsuccessful shocks were delivered which exhausted therapy and the patient had to be externally shocked.The shocks did not convert the rhythm and the patient coded in which cpr was performed.The patient was resuscitated successfully.The boston scientific turned off device therapy and the patient was currently being monitored in the intensive care unit (icu).It was noted that the right ventricular (rv) lead exhibited high out of range shock impedances measuring greater than 145 ohms and some noise.Over the last year there was a gradual decrease in shock impedances.Boston scientific technical services (ts) recommended to evaluate the pulse generator and lead system integrity and to consider replacement of one or both components.Ts found that anti-tachycardia pacing (atp) did accelerate the rhythm from ventricular tachycardia (vt) to ventricular fibrillation (vf) which resulted in eight 41 joule shocks that did not convert the rhythm.A painless shock impedance test was performed and the results were normal.Subsequently, the crt-d was explanted and replaced and the right ventricular (rv) lead was surgically abandoned.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Patient code 3191 captures the surgical intervention.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) declared code 1005, which indicates an open circuit was detected during shock delivery.Several unsuccessful shocks were delivered which exhausted therapy and the patient had to be externally shocked.The shocks did not convert the rhythm and the patient coded in which cpr was performed.The patient was resuscitated successfully.The boston scientific turned off device therapy and the patient was currently being monitored in the intensive care unit (icu).It was noted that the right ventricular (rv) lead exhibited high out of range shock impedances measuring greater than 145 ohms and some noise.Over the last year there was a gradual decrease in shock impedances.Boston scientific technical services (ts) recommended to evaluate the pulse generator and lead system integrity and to consider replacement of one or both components.Ts found that anti-tachycardia pacing (atp) did accelerate the rhythm from ventricular tachycardia (vt) to ventricular fibrillation (vf) which resulted in eight 41 joule shocks that did not convert the rhythm.A painless shock impedance test was performed and the results were normal.Subsequently, the crt-d was explanted and replaced and the right ventricular (rv) lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10687911
• MDR Text Key: 211621284
• Report Number: 2124215-2020-20886
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• 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: 10/10/2021

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: 12/18/2019
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 125900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: 08/23/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR