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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G447
Device Problems High impedance (1291); Difficult to Insert (1316)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during the implant procedure the physician experienced difficulty inserting the right ventricular (rv) lead into the cardiac resynchronization therapy defibrillator (crt-d) header.The pacing impedances were out-of-range (oor), measuring greater than 3000 ohms.The crt-d was removed/replaced prior to pocket closure, which resolved the issue.No adverse patient effects were reported.
 
Manufacturer Narrative
Patient code 3191 was used to capture the prolonged procedure.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 a df-4 lead into the header of this device resulting in high pacing impedances.Please refer to the description for more information regarding the specific circumstances of this event.
 
Event Description
It was reported that during the implant procedure the physician experienced difficulty inserting the right ventricular (rv) lead into the cardiac resynchronization therapy defibrillator (crt-d) header.The pacing impedances were out-of-range (oor), measuring greater than 3000 ohms.The crt-d was removed/replaced prior to pocket closure, which resolved the issue.The rv lead remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
Patient code 3191 was used to capture the prolonged procedure.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 a df-4 lead into the header of this device resulting in high pacing impedances.Please refer to the description for more information regarding the specific circumstances of this event.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.High power visual examination of the device header and case noted no anomalies.All setscrews were able to move freely.A test lead with a df4 connector was inserted in the rv port successfully and the setscrew was able to be secured.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.
 
Event Description
It was reported that during the implant procedure the physician experienced difficulty inserting the right ventricular (rv) lead into the cardiac resynchronization therapy defibrillator (crt-d) header.The pacing impedances were out-of-range (oor), measuring greater than 3000 ohms.The crt-d was removed/replaced prior to pocket closure, which resolved the issue.The rv lead remains in service.No adverse patient effects were reported.
 
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Brand Name
RESONATE X4 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 Key10620674
MDR Text Key209604733
Report Number2124215-2020-17406
Device Sequence Number1
Product Code NIK
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,foreig
Type of Report Initial,Followup,Followup
Report Date 04/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/05/2022
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number237730
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Date Manufacturer Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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