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

Model Number 0692

Device Problems Over-Sensing (1438); Pocket Stimulation (1463); Ambient Noise Problem (2877); Device Contamination With Biological Material (2908); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Muscle Stimulation (1412)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that following the implant procedure, the patient complained of stimulation of the pectoral muscle.Upon interrogation, noise was noted on the pacing and shock channels of the right ventricular (rv) lead.Several episodes were recorded, but no therapy was delivered.During the revision procedure, the rv lead was found to be dislodged.The rv lead was extracted and the helix would not fully extend.As there was tissue in the helix, this rv lead was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Resistance tests were completed to assess lead electrical performance.Measurements throughout these tests were within normal limits.Tissue was found to be entwined in the helix which resulted in the helix not being able to fully retract.

Event Description

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• 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: 5373460
• MDR Text Key: 36228460
• Report Number: 2124215-2015-16811
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

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: 10/15/2017
• Device Model Number: 0692
• Other Device ID Number: RELIANCE 4-FRONT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention