MAUDE Adverse Event Report: HISTORICAL CPI ST. PAUL TRANSVENOUS; IMPLANTABLE LEAD

Model Number 4260

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Capturing Problem (2891); Material Integrity Problem (2978)

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

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

The lead was surgically abandoned and was not returned for testing.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 during the elective procedure to replace this patient's competitive device, this lead was kinked during efforts to insert the lead into the header of the replacement device.Pacing therapy was intermittent due to oversensing, thresholds were high and pacing impedance measurements were greater than 2000 ohms on the right ventricular (rv) channel.The lead was removed from service and replaced.No adverse patient effects were reported.

• Brand Name: TRANSVENOUS
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): HISTORICAL CPI ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): HISTORICAL CPI ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5823968
• MDR Text Key: 51174938
• Report Number: 2124215-2016-08799
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/1994
• Device Model Number: 4260
• Other Device ID Number: ---
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 66 YR