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

Model Number 0692

Device Problems Low impedance (2285); Capturing Problem (2891); Device Contamination With Biological Material (2908); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

The explanted lead was not expected to be returned for analysis.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 at the device check one week post-implant, this right ventricular (rv) lead exhibited increased pacing threshold measurements and a decrease in pacing impedance measurements.An x-ray showed the lead had moved slightly.A revision procedure was planned to reposition the lead the following day.At the revision, the helix could not be fully retracted.During manipulation, the lead was released from the heart tissue and was removed from the patient.Visual inspection noted tissue caught in the helix; the tissue was removed as much as possible, but the helix still did not function properly, requiring 20 turns to extend when the lead was straight.Therefore, a new lead of the same model was implanted without complication.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7618839
• MDR Text Key: 111646326
• Report Number: 2124215-2018-08766
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2020
• Device Model Number: 0692
• Other Device ID Number: RELIANCE 4-FRONT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2018
• 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: 0692; 7741; D433
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR