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

Model Number U125

Device Problems False Positive Result (1227); High impedance (1291); Over-Sensing (1438)

Patient Problem Electric Shock (2554)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

It was reported that high out of range pace impedance measurements were reported when it comes to this device.Technical services (ts) discussed checking the signal artifact monitoring (sam) events to identify the impedance measurements at the time the sam event was created.Further review of the case by ts noted that the lead safety switch (lss) was on, and this was a contraindication for unipolar pacing with a pacemaker and s-icd system.Ts noted that in case of out of range impedance measurements this device will go into unipolar pacing which may affect ventricular fibrillation detection for the s-icd.At this time no further change were made and the device remains implanted.No adverse patient effects were reported.

Event Description

It was reported that high out of range pace impedance measurements were reported when it comes to this device.Technical services (ts) discussed checking the signal artifact monitoring (sam) events to identify the impedance measurements at the time the sam event was created.Further review of the case by ts noted that the lead safety switch (lss) was on, and this was a contraindication for unipolar pacing with a pacemaker and s-icd system.Ts noted that in case of out of range impedance measurements this device will go into unipolar pacing which may affect ventricular fibrillation detection for the s-icd.At this time no further change were made and the device remains implanted.No adverse patient effects were reported.

• Brand Name: VALITUDE 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: 10255172
• MDR Text Key: 198343143
• Report Number: 2124215-2020-12231
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2022
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 715497
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 07/23/2020
• Patient Sequence Number: 1