MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL INSYNC III; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 8042B

Device Problems Failure to Capture (1081); Unable to Obtain Readings (1516); Battery Problem: High Impedance (2947); Missing Test Results (3267)

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

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 310c29 mitral valve, implanted (b)(6) 2007.This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.

Event Description

It was reported that after the cardiac resynchronization therapy pacemaker (crt-p) reached the elective replacement indicator (eri), high battery impedance and right ventricular pacing capture failure were observed.Lead impedance and battery voltage measurements were also not available for evaluation.The device was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device found high internal battery resistance.This device was reported as included in the field action noted and returned product investigation found the device performed as described in the field action.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): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6923566
• MDR Text Key: 88755312
• Report Number: 9614453-2017-03690
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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: 07/28/2009
• Device Model Number: 8042B
• Device Catalogue Number: 8042B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0342-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 91 YR
• Patient Weight: 65