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

Model Number U225

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

Available information indicates this device remains implanted and in service.This report will be updated if additional information is received.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited an abrupt change in impedance measurements.The lead safety switch (lss) was triggered on the right ventricular (rv) lead (unknown manufacturer) and the lead was now in the unipolar configuration.It was noted the patient had been seen in the clinic, then the next day an alert was issued in the remote monitoring system due to this out-of-range impedance measurement on the rv lead.It was noted the right atrial (ra) lead (unknown manufacturer) showed an unusual impedance pattern, but no out-of-range measurements.The leads were believed to be epicardial leads.Technical services recommended bringing the patient back in to the clinic to perform troubleshooting on the rv lead.A request was made for the field representative to obtain additional details about this case, including the name of the hospital and physician, details of the implanted leads, as well as the resolution.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited an abrupt change in impedance measurements.The lead safety switch (lss) was triggered on the right ventricular (rv) lead (unknown manufacturer) and the lead was now in the unipolar configuration.It was noted the patient had been seen in the clinic, then the next day an alert was issued in the remote monitoring system due to this out-of-range impedance measurement on the rv lead.It was noted the right atrial (ra) lead (unknown manufacturer) showed an unusual impedance pattern, but no out-of-range measurements.The leads were believed to be epicardial leads.Technical services recommended bringing the patient back in to the clinic to perform troubleshooting on the rv lead.A request was made to the field representative, however no updated information was available on the resolution of this complaint.No adverse patient effects were reported.

Manufacturer Narrative

Available information indicates this device remains implanted and in service.This report will be updated if additional information is received.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.

• Brand Name: VISIONIST CRT-P
• 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
• MDR Report Key: 9281712
• MDR Text Key: 165991073
• Report Number: 2124215-2019-24242
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2020
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 710673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2019
• Patient Sequence Number: 1