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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE Back to Search Results
Model Number G247
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Difficult to Insert (1316); Off-Label Use (1494); Unexpected Therapeutic Results (1631)
Patient Problem Unspecified Infection (1930)
Event Date 05/17/2021
Event Type  Injury  
Event Description
It was reported that the patient experienced five appropriate shocks; the first four did not convert the patient's arrhythmia, and the final shock converted the rhythm.The physician decided to implant a subcutaneous (sq) array and adapter to facilitate future shock therapy as a result of the first four shocks not converting the patient.During the implant procedure, upon connecting the adapter to the device, the right ventricular (rv) and left ventricular (lv) leads had high out-of-range pace impedances of greater than 3000 ohms, and noise appeared on the rv channel.Shock impedance also had a high out-of-range value of greater than 200 ohms.Then, the physician noticed the rv lead was under-inserted into the header and used mineral oil in an attempt to fully insert the lead, but the lead would not fully insert and the impedance and noise issues persisted.The physician decided to cut and peel the white silicone of the lead terminal with a scalpel to see whether the lead was completely entered into the port of the adaptor, however, the problem persisted.A pacing system analyzer was used to evaluate the rv lead integrity, and all measurements were normal.Finally, the physician decided to stop the surgical intervention, leave the system as it was before the surgery, and remove the sq array and adapter.The patient remained hospitalized until a second procedure was performed, in which the physician elected to remove the rv lead and the replace it with a new double-coil rv lead.The new rv lead was placed on the right side as the physician thought the left side could be infected.No additional 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 noted evidence indicating difficulty may have been encountered fully inserting an is-1/df-1 lead into the header of this device resulting in the impedance issues, therapy delivery/effectiveness issues, and noise.Please refer to the description for more information regarding the specific circumstances of this event.
 
Event Description
It was reported that the patient experienced five appropriate shocks; the first four did not convert the patient's arrhythmia, and the final shock converted the rhythm.The physician decided to implant a subcutaneous (sq) array and adapter to facilitate future shock therapy as a result of the first four shocks not converting the patient.During the implant procedure, upon connecting the adapter to the device, the right ventricular (rv) and left ventricular (lv) leads had high out-of-range pace impedances of greater than 3000 ohms, and noise appeared on the rv channel.Shock impedance also had a high out-of-range value of greater than 200 ohms.Then, the physician noticed the rv lead was under-inserted into the header and used mineral oil in an attempt to fully insert the lead, but the lead would not fully insert and the impedance and noise issues persisted.The physician decided to cut and peel the white silicone of the lead terminal with a scalpel to see whether the lead was completely entered into the port of the adaptor, however, the problem persisted.A pacing system analyzer was used to evaluate the rv lead integrity, and all measurements were normal.Finally, the physician decided to stop the surgical intervention, leave the system as it was before the surgery, and remove the sq array and adapter.The patient remained hospitalized until a second procedure was performed, in which the physician elected to remove the rv lead and the replace it with a new double-coil rv lead.The new rv lead was placed on the right side as the physician thought the left side could be infected.No additional adverse patient effects were reported.
 
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Brand Name
VIGILANT X4 CRT-D
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key12215577
MDR Text Key263096542
Report Number2124215-2021-14976
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589287
UDI-Public00802526589287
Combination Product (y/n)N
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/30/2021
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number217275
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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