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

Model Number V173

Device Problems Signal Artifact/Noise (1036); High impedance (1291)

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

Event Date 06/27/2020

Event Type  malfunction  

Event Description

It was reported that during a routine interrogation of the cardiac resynchronization therapy pacemaker (crt-p), prior to replacement for elective replacement indicator (eri), it was noted that four months earlier the lead safety switch (lss) had triggered for another manufacturer's right atrial (ra) lead due to high out of range pacing impedance measurements.Review found that prior to the lss the impedances had fluctuated and then post lss they had stabilized in the 300 ohm range.Boston scientific technical services (ts) also noted a considerable amount of noise prior to the lss.Ts suggested troubleshooting options.During the change out procedure the crt-p was explanted as planned for reported normal battery depletion and the ra lead remained in service with in range impedance measurements.No adverse patient effects were reported.

Event Description

It was reported that during a routine interrogation of the cardiac resynchronization therapy pacemaker (crt-p), prior to replacement for elective replacement indicator (eri), it was noted that four months earlier the lead safety switch (lss) had triggered for another manufacturer's right atrial (ra) lead due to high out of range pacing impedance measurements.Review found that prior to the lss the impedances had fluctuated and then post lss they had stabilized in the 300 ohm range.Boston scientific technical services (ts) also noted a considerable amount of noise prior to the lss.Ts suggested troubleshooting options.During the change out procedure the crt-p was explanted as planned for reported normal battery depletion and the ra lead remained in service with in range impedance measurements.No adverse patient effects were reported.

Manufacturer Narrative

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 fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE PACEMAKER WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11042364
• MDR Text Key: 222698883
• Report Number: 2124215-2020-25171
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 104101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1
• Patient Age: 94 YR