MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE; IMPLANTABLE LEAD

Model Number 0184

Device Problems Pocket Stimulation (1463); Capturing Problem (2891)

Patient Problem Muscle Stimulation (1412)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

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 this right ventricular (rv) lead exhibited high threshold.This patient also experienced stimulation at higher outputs.Additional information indicates the cause of high threshold was not determined.It was also not known if high pacing threshold was attributed to the lead or device.This lead was abandoned surgically.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: IMPLANTABLE LEAD
• 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: 6267144
• MDR Text Key: 65406553
• Report Number: 2124215-2017-00818
• Device Sequence Number: 1
• Product Code: LWS
• 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: Physician
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2010
• Device Model Number: 0184
• Other Device ID Number: ENDOTAK RELIANCE G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2008
• 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: 0184; 4135; E110
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR