MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE DEFIBRILLATION LEAD

Model Number 0672

Device Problems Mechanical Problem (1384); Pocket Stimulation (1463); Off-Label Use (1494); Difficult to Remove (1528); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); No Code Available (3191)

Event Date 09/23/2019

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

It was reported that this right ventricular (rv) lead exhibited an increase in pacing thresholds due to dislodgement.Furthermore, the lead had caused the patient to experience diaphragmatic stimulation.This lead was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.Correction to fields: device eval by manufacturer? and h6: evaluation conclusion codes.

Event Description

Additional information was received which indicated that the ventricular (rv) lead exhibited a decrease in impedances and sensing.The patient experienced discomfort in the device pocket.A rv lead micro-perforation or dislodgement was suspected.Subsequently, a revision procedure was performed.The physician planned to reposition the rv lead and the device subpec.The physician attempted to reposition the lead, but the helix mechanism would not fully extend after 70 turns.It was also noted that the left subclavian was occluded.The icd and rv lead were explanted.The patient would either get a new system implanted on the right side or an subcutaneous implantable cardioverter defibrillator (s-icd).No additional adverse patient effects were reported.

Manufacturer Narrative

This lead was returned to boston scientific's post market quality assurance laboratory with the helix mechanism in a retracted position.Visual inspection found dried blood/body fluid around the helix and lumen, which confirmed the helix issues.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 analysis did not identify any lead characteristics that would have caused or contributed to the reported high thresholds, impedances issues, sensing issues, diaphragmatic stimulation, dislodgement, and removal difficulty.

Event Description

This supplemental report is being filed as the device evaluation was completed.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE DEFIBRILLATION LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9270385
• MDR Text Key: 164802894
• Report Number: 2124215-2019-23431
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592829
• UDI-Public: 00802526592829
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2020
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 103232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR