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

Model Number 0693

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

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, during the implant of this right ventricular (rv) lead, oversensing of noise led to significant pacing inhibition.Blood was observed in the lead insulation and lead damage was suspected.This rv lead was explanted and replaced prior to pocket closure.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The complete lead was returned severed in two segments.Visual inspection revealed a cut in the insulation 23 centimeters from the terminal pin.Body fluid/blood was visible in the lumen and was assumed to have entered through the cut.Resistance tests were completed on both segments to assess lead electrical performance.Measurements throughout these tests were within normal limits.Laboratory analysis was able to confirm the field observation of lead damage, but there were no lead characteristics that would have contributed to the reported electrical observations.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6475610
• MDR Text Key: 72448561
• Report Number: 2124215-2017-00838
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2016
• Device Model Number: 0693
• Other Device ID Number: RELIANCE 4-FRONT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• 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: 0692; 0693