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

Model Number V272

Device Problem Impedance Problem (2950)

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

Event Date 10/21/2014

Event Type  malfunction  

Manufacturer Narrative

Based on data analysis of (5) model v272 devices, (9) yellow alert (left ventricular pacing lead impedance out of range), and (8) yellow alert (atrial pacing lead impedance out of range) were identified.The alert dates occurred from (b)(6) 2014 through (b)(6) 2019.This investigation will be updated should further information be provided.

Event Description

It was reported that boston scientific imagineif team conducted a retrospective data analysis (latitude imagineif data study (phase 2)).Based on data analysis, follow-up patient populations were stratified into two groups with a goal to determine which patients could be followed remotely (computer-based health care) versus those patients that may require in-clinic follow-up.Data from 20,000 (5000 icds, 5000 pacemakers, 5000 crt-p and 5000 crt-d) devices implanted in the united states was collected using latitude nxt and de-identified for analysis.All data was used in accordance with patient confidentiality laws, regulations, and data use agreements.A listing of possible malfunctions or product deficiencies that would satisfy the definition of a complaint were sent to the complaint management center (cmc) for further processing.Red alerts from the patient latitude monitoring are device conditions that could potentially leave the patient without available device therapy.Each individual red alert needs to be assessed by the clinician or physician.Yellow alerts are declared when a certain device condition or patient heart-health issue is detected that may warrant clinician review or investigation.

• Brand Name: INTUA CRT-P
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (WITH CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; cashel rd.; clonmel, tipperary ireland ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9275426
• MDR Text Key: 168907433
• Report Number: 2124215-2019-23739
• Device Sequence Number: 1
• Product Code: NKE
• 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: Other
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1