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

Model Number G151

Device Problem High impedance (1291)

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

Event Date 10/31/2020

Event Type  malfunction  

Event Description

It was reported that this patient with a cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead exhibited a sudden increase in pacing impedances.Additionally, the pacing impedances are currently high out of range measuring 2363 ohms.The patient was brought into the clinic for evaluation and the health care professional re-programmed the device and changed the pacing vector to be lv tip.Technical services (ts) reviewed and suggested that the pacing vector lv tip may be causing the issue.Ts recommended to continue to monitor however, if noise is seen on the lv channel should consider changing pacing vector to lv ring.At this time, this crt-d and lv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that this patient with a cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead exhibited a sudden increase in pacing impedances.Additionally, the pacing impedances are currently high out of range measuring 2363 ohms.The patient was brought into the clinic for evaluation and the health care professional re-programmed the device and changed the pacing vector to be lv tip.Technical services (ts) reviewed and suggested that the pacing vector lv tip may be causing the issue.Ts recommended to continue to monitor however, if noise is seen on the lv channel should consider changing pacing vector to lv ring.At this time, this crt-d and lv lead remains in service.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 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.

• 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: 11104536
• MDR Text Key: 224846972
• Report Number: 2124215-2020-25810
• 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: health professional
• 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: 01/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2020
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 126683
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR