MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE DEVICE

Model Number V173

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Syncope (1610); Dizziness (2194)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced syncope.The patient also has a neurostimulator.The clinic stated that when the output on the neurostimulator increases, the threshold on the pacemaker increases and there is loss of capture (loc).The clinic has stated they have tested this interaction between the crt-p and neurostimulator within the clinic and obtained the same results with the patient experiencing dizziness.It was noted the patient has been paralyzed for a number of years from previous auto accident with spinal cord injuries and has recently been able to be more active.The field representative noted there were no noise on the leads and it is unknown if the increase in thresholds occur with one or all leads.Ts discussed possible programming changes to either the output of the neurostimulator to reduce the risk of loc or possibly increase cardiac device output.The crt-p remains in service and no additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8588810
• MDR Text Key: 144384965
• Report Number: 2124215-2019-09472
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 05/07/2019

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 Date: 10/21/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 104818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 36 YR