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

Model Number V273

Device Problems Over-Sensing (1438); Low impedance (2285); Device Sensing Problem (2917)

Patient Problems Dizziness (2194); Palpitations (2467)

Event Date 11/20/2018

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited noise and oversensing on the right ventricular (rv) lead.The patient experienced lightheadedness and palpitations.The noise was recreated with isometrics.In addition, the rv lead impedances were stable around 500 ohms; however, occasionally they were low and out of range measuring less than 200 ohms.Boston scientific technical services (ts) discussed this could be the early stages of a lead insulation breach.Subsequently, a revision procedure was performed and the rv lead was surgically abandoned and replaced.The crt-p remains in service.No additional adverse patient effects were reported.

Event Description

This supplemental report is being filed as the conclusion code was updated.

• Brand Name: INTUA
• 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
• 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: 8250122
• MDR Text Key: 133128901
• Report Number: 2124215-2019-00148
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2017
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 118570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR