MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0295

Device Problems Pocket Stimulation (1463); Human-Device Interface Problem (2949)

Patient Problems Muscle Stimulation (1412); Pain (1994); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/08/2015

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 patient experienced neck and back pain.The patient was found to have a thrombus and was treated medically.Subsequently, an echocardiogram was performed which revealed a small pericardial effusion.The lead measurements were stable but due to the location of the pericardial effusion the physician suspected that the competitor's right atrial (ra) lead may have perforated.Additionally, it was observed that the right ventricular (rv) lead exhibited high outputs and produced pain and small phrenic nerve stimulation.It was alleged that the rv lead likely perforated also.At this time, the physician plans to continue to monitor.No further complications have been 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: 5373260
• MDR Text Key: 36197860
• Report Number: 2124215-2015-16547
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/08/2015

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: 09/24/2016
• Device Model Number: 0295
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• 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): Life Threatening