MAUDE Adverse Event Report: IPG MFG SWITZERLAND INSYNC III; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 8042B

Device Problems Failure to Capture (1081); Reset Problem (3019); Missing Test Results (3267)

Patient Problems Bradycardia (1751); Dizziness (2194)

Event Date 09/30/2014

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department (ed) with dizziness/presyncope and their right ventricular (rv) lead was not capturing the right ventricle at max output, and the patient's heart rate in the 30's.Upon interrogation the field representative was unable to obtain the battery voltage, and also noted the left ventricular (lv) lead was not capturing when the lead was reactivated.It was later discovered that the bi-v implantable pulse generator (ipg) had triggered elective replacement indicator (eri) and experienced a power on reset (por) at the same time as interrogation.The device was removed and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device memory found the eri (elective replacement indicator) is the result of high internal battery resistance.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INSYNC III
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4316092
• MDR Text Key: 16991972
• Report Number: 9614453-2014-02990
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2009
• Device Model Number: 8042B
• Device Catalogue Number: 8042B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided; 03/13/2015
• Supplement Dates FDA Received: 06/10/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2007
• 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
• Treatment: 407658, LEAD / 419488, LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00078 YR