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

Model Number G151

Device Problems High impedance (1291); Noise, Audible (3273)

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

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the day after implant, a patient implanted with a cardiac resynchronization therapy defibrillator (crt-d) heard beep tones.A few days later, impedance testing revealed high, out-of-range pace impedance measurements greater than 2,000 ohms on the right ventricular (rv) channel.The physician increased the lead impedance alert threshold to greater than 2,500 ohms.This device remains in service at this time.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device's spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that the day after implant, a patient implanted with a cardiac resynchronization therapy defibrillator (crt-d) heard beep tones.A few days later, impedance testing revealed high, out-of-range pace impedance measurements greater than 2,000 ohms on the right ventricular (rv) channel.The physician increased the lead impedance warning limit to greater than 2,500 ohms.This device remains in service at this time.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
• MDR Report Key: 10606446
• MDR Text Key: 209175429
• Report Number: 2124215-2020-16231
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2020
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 128257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR