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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE DEVICE Back to Search Results
Model Number G151
Device Problem High impedance (1291)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 11/16/2020
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited a high out of range pace impedance measurement greater than 3000 ohms on the right ventricular (rv) lead.It was noted that the patient was in the clinic two days after the out of range measurement to receive a cardioversion using their crt-d device and no noise or out of range measurements were observed.Boston scientific technical services (ts) reviewed device data and noted no noise observed in stored episodes or on the presenting electrogram.Ts indicated the rv pace impedance had been relatively stable prior to the out of range measurement, normally in the approximately 400 ohm range with some measurements in the 700 ohm range.Ts provided guidance to the boston scientific representative (rep) that this could be the start of a rv lead issue or a possible device header spring contact issue, though both the device and rv lead are boston scientific products.Ts also indicated it could be electromagnetic interference, but this is less likely since the other lead impedance measurements did not show the same issue.Ts indicated they can consider configuring the non-sustain ventricular tachycardia and non-physiologic noise alerts and continue to monitor for now.It was also noted that the device had tones programmed on for both the rv pace and shock impedance daily measurements.The products remain in-service.No patient symptoms or adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited a high out of range pace impedance measurement greater than 3000 ohms on the right ventricular (rv) lead.It was noted that the patient was in the clinic two days after the out of range measurement to receive a cardioversion using their crt-d device and no noise or out of range measurements were observed.Boston scientific technical services (ts) reviewed device data and noted no noise observed in stored episodes or on the presenting electrogram.Ts indicated the rv pace impedance had been relatively stable prior to the out of range measurement, normally in the approximately 400 ohm range with some measurements in the 700 ohm range.Ts provided guidance to the boston scientific representative (rep) that this could be the start of a rv lead issue or a possible device header spring contact issue, though both the device and rv lead are boston scientific products.Ts also indicated it could be electromagnetic interference, but this is less likely since the other lead impedance measurements did not show the same issue.Ts indicated they can consider configuring the non-sustain ventricular tachycardia and non-physiologic noise alerts and continue to monitor for now.It was also noted that the device had tones programmed on for both the rv pace and shock impedance daily measurements.The products remain in-service.No patient symptoms or 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.
 
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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 Key11104820
MDR Text Key224794711
Report Number2124215-2020-27127
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534638
UDI-Public00802526534638
Combination Product (y/n)N
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/02/2020
Device Model NumberG151
Device Catalogue NumberG151
Device Lot Number127572
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received01/02/2021
Supplement Dates Manufacturer Received01/12/2021
Supplement Dates FDA Received05/04/2021
Patient Sequence Number1
Patient Age74 YR
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