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

Model Number 0693

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Human-Device Interface Problem (2949)

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

Event Date 02/29/2016

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 dislodged while implanting the left ventricular lead.After repositioning the rv lead, loss of capture and diaphragm stimulation were noted.Immediately, the patient began not feeling well and had very low tension.A perforation resulting in pericardial effusion was suspected and confirmed through an ultrasound.A pericardial puncture was performed and the rv lead was successfully repositioned.No additional adverse patient effects were reported.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5601415
• MDR Text Key: 43446113
• Report Number: 2124215-2016-03715
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/29/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2016
• Device Model Number: 0693
• Other Device ID Number: RELIANCE 4-FRONT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• 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): Hospitalization; Life Threatening; Disability