MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0292

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Device Dislodged or Dislocated (2923)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/05/2015

Event Type  Injury  

Event Description

Boston scientific received information that this patient complained of diaphragmatic stimulation and chest discomfort.The physician assessed the patient and heard a pericardial rub and observed high threshold on this right ventricular (rv) lead.The patient was scheduled for surgery for replacement of this lead.Additional information received that echocardiogram result showed that the tip of this lead was in the pericardial space.This rv lead was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

(b)(4).This lead has been returned.Boston scientific has concluded it is unlikely that lead characteristics caused or contributed to the reported clinical observations.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• 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 55112 ; 6515824786
• MDR Report Key: 4657581
• MDR Text Key: 15246187
• Report Number: 2124215-2015-00998
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• 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: 01/06/2015

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: 10/21/2016
• Device Model Number: 0292
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2014
• 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; Other