MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV INGENIO; IMPLANTABLE PULSE GENERATOR

Model Number V273

Device Problem Over-Sensing (1438)

Patient Problem No Information (3190)

Event Date 04/01/2017

Event Type  malfunction  

Manufacturer Narrative

With the exception of model numbers, all other pertinent patient and product information was de-identified.As no further information concerning this report is expected, our investigation is complete.

Event Description

In the interest of continuous improvement, a study was undertaken by boston scientific¿s research and development to evaluate potential device enhancements to detect a phenomenon known as ¿mv/rrt noise¿.The work from this research study may be subsequently used to create a new feature in the device that detects and resolves this mv/rrt noise issue.A large data set of episode electrograms from boston scientific¿s latitude remote monitoring system will be acquired.Mv/rrt noise in the data set will be characterized.Once characterized, proposed device enhancement features will be tested.Based on review of stored data by the adjudication committee involving 5 model#v273 devices, the following clinical observation was identified in some of the episodes: oversensing (greater than 2 seconds of asystole).

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT PUERTO RICO BV
• Manufacturer (Section G): GUIDANT PUERTO RICO BV
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6768291
• MDR Text Key: 81855023
• Report Number: 2124215-2017-14045
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V273
• Other Device ID Number: INTUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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