MAUDE Adverse Event Report: CPI PLANT - ST. PAUL ENDOTAK RELIANCE; IMPLANTABLE LEAD

Model Number 0692

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

Patient Problems Muscle Stimulation (1412); Twiddlers Syndrome (2114)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the one month post implant follow-up, there was no capture in the ventricle and unusual wave morphology on the shock electrogram.Testing was unable to measure atrial or ventricular waves.It was confirmed the patient was in an underlying rhythm.There was no capture in the atrium or the ventricle at maximum outputs and this generated diaphragm stimulation from the ventricle.The device was programmed off and the patient was hospitalized until lead dislodgement could be assessed.Fluoroscopy confirmed that both leads were dislodged.It was determined the dislodgements were a result of twiddler's syndrome.As a result, a revision procedure was performed to reposition the leads.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5599076
• MDR Text Key: 43371095
• Report Number: 2124215-2016-01502
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2017
• Device Model Number: 0692
• Other Device ID Number: RELIANCE 4-FRONT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2015
• 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
• Treatment: 7741
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention