MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0292

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Ambient Noise Problem (2877)

Patient Problem Muscle Stimulation (1412)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Resistance and pressure tests were completed to assess lead electrical performance and insulation integrity.Measurements throughout these tests were within normal limits.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.

Event Description

Boston scientific received information that this patient's cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead exhibited noise and loss of capture.This patient is dependent, and a revision procedure was performed.During the revision procedure, muscle stimulation occurred, mostly during electrocautery.The device and lead were replaced with products from another manufacturer.No additional adverse patient effects were reported.

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

Additional information was received indicating this patient experienced asystole for greater than 2 seconds as a result of the rv lead loss of capture.No additional adverse patient effects were reported.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5387396
• MDR Text Key: 36703376
• Report Number: 2124215-2016-01362
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

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: 06/27/2017
• Device Model Number: 0292
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 01/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2015
• 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
• Patient Age: 82 YR