MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0292

Device Problems Difficult To Position (1467); Inappropriate/Inadequate Shock/Stimulation (1574); Device Contamination With Biological Material (2908); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that, post pocket closure, this patient was in atrial flutter and received an inappropriate shock because the rv lead dislodged into the atrium.The decision was made to explant and replace this rv lead.Upon explanting the rv lead, myocardial tissue was found on the helix.It was noted, during implant, the lead had to be repositioned a few times.A new rv lead was implanted without complication.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.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Testing was also completed to assess the outer insulation integrity of the lead.This test did not pass because there was a cut in the insulation, which was induced during the explant procedure.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.Analysis did find a cut in the insulation, which was likely induced during the explant procedure.

• Brand Name: ENDOTAK RELIANCE
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7189566
• MDR Text Key: 97275494
• Report Number: 2124215-2017-19220
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/09/2019
• Device Model Number: 0292
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• 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
• Patient Age: 84 YR