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

Model Number U225

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

It was reported that upon remote device data review, a red alert was seen from the remote communicator.The alert was for high, out of range pacing impedance (>3000 ohms) from the right ventricular (rv) lead.The patient was seen in clinic where provocative maneuvers were performed and the device was reprogrammed.Upon transfer to another clinic, however, this red alert for high, out of range impedance occurred again.Boston scientific technical services were contacted and discussed replacing the communicator and performing further rv lead integrity testing.At this time, the system remains implanted and in service.The patient was stable with no adverse consequences.

Manufacturer Narrative

This report is being filed for additional information in b5.

Event Description

It was reported that upon remote device data review, a red alert was seen from the remote communicator.The alert was for high, out of range pacing impedance (>3000 ohms) from the right ventricular (rv) lead.The patient was seen in clinic where provocative maneuvers were performed and the device was reprogrammed.Upon transfer to another clinic, however, this red alert for high, out of range impedance occurred again.Boston scientific technical services were contacted and discussed replacing the communicator and performing further rv lead integrity testing.The patient was subsequently seen in-clinic where provocative maneuvers and diagnostic imaging were performed again.Because all measurements were stable and within range, the physician elected to continue with remote monitoring.The communicator was also reset and the event was resolved.At this time, the system remains implanted and in service.The patient was stable with no adverse consequences.

• 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: 10278495
• MDR Text Key: 199159472
• Report Number: 2124215-2020-14142
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2019
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 706561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Patient Sequence Number: 1
• Patient Age: 69 YR