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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Difficult to Remove (1528); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  Injury  
Manufacturer Narrative
If additional information is received a supplemental report will be submitted.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker was explanted due to being on an advisory.It was noted that during the procedure, the right ventricular lead was found to be stuck in the header of the device, requiring the use of bone cutters to remove.The lead was successfully removed and used with the new device that was implanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Pacing and sensing functions were tested and the device was verified to operate as expected.A longevity calculation was completed and it was confirmed that the device did not meet longevity expectations.Device memory was reviewed and no faults or errors were noted.It was also noted that the device sensed in the atrial chamber (b)(4) of the time while implanted with prolonged high atrial rates.The device was then exposed to simulated heart load conditions, and the 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.Chronic high atrial rates, as occurred with this device, can reduce longevity in devices that are programmed ddd(r) with atrial sensing on.Device power consumption increases proportional to the additional processing for sensed atrial events.As a result, the high rate of atrial sensing was determined to be the cause of the longevity being lower than expected.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker was explanted due to being on an advisory.It was noted that during the procedure, the right ventricular lead was found to be stuck in the header of the device, requiring the use of bone cutters to remove.The lead was successfully removed and used with the new device that was implanted.No additional adverse patient effects were reported.
 
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Brand Name
INVIVE
Type of Device
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key12620223
MDR Text Key276356288
Report Number2124215-2021-20277
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/15/2016
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number105529
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/09/2021
Initial Date FDA Received10/12/2021
Supplement Dates Manufacturer Received03/02/2022
Supplement Dates FDA Received04/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age83 YR
Patient SexFemale
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