MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0293

Device Problems Failure to Capture (1081); Device Contamination With Biological Material (2908); Device Dislodged or Dislocated (2923)

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

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory it was noted that the complete lead was returned severed in two segments at 10 cm from the terminal pin.Trace tissue was observed on the extended helix.Visual inspection of the distal segment revealed that the lead was twisted.Testing was completed to assess lead electrical performance and measurements were within normal limits.Analysis was unable to confirm the field allegations of loss of capture due to dislodgement.

Event Description

Boston scientific received information that the right ventricular (rv) lead exhibited loss of capture due to a dislodgement.A revision procedure was performed where the lead was repositioned.Three days later the lead dislodged again and another revision procedure was performed.Another revision procedure was performed where the physician noted tissue in the helix at the lead tip.The physician removed the tissue and explanted the rv lead.A new lead was successfully replaced.No additional adverse patient effects were 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7409050
• MDR Text Key: 104760498
• Report Number: 2124215-2018-05775
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2019
• Device Model Number: 0293
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• 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: 0293; 1782TC; 7001; G150; MISMATCH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR