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

Model Number 0675

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439); Pocket Stimulation (1463); Low impedance (2285)

Patient Problems Undesired Nerve Stimulation (1980); No Code Available (3191)

Event Date 09/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lead has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this patient was in the following physicians clinic and this right ventricular (rv) lead was exhibiting a low out of range shock impedance measurement of zero (0), a pace impedance measurement of 259 ohms and the device pocket was exhibiting pocket stimulation.The patient is device therapy dependent.Boston scientific technical services (ts) indicated that there was a previous stored episode in which the associated implantable cardioverter defibrillator (icd) device provided 5 shocks for a true ventricular tachycardia (vt) and the shock impedance was 39 ohms for the delivered shocks.In addition, there was another stored episode that exhibited noise with a 5 second pause in pacing therapy.The current rhythm was noted to be a normal sinus rhythm at a rate of 70 beats per minute (bpm), but the device is still pacing at the lower rate limit of 50 bpm.Ts indicating that it appears the lead is no longer sensing appropriately.Ts discussed with the boston scientific representative (rep) that they are concerned that there is a lead insulation breach, the patient should be considered unprotected and the lead needs to be replaced.The rv lead was subsequently explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this patient was in the following physicians clinic and this right ventricular (rv) lead was exhibiting a low out of range shock impedance measurement of zero (0), a pace impedance measurement of 259 ohms and the device pocket was exhibiting pocket stimulation.The patient is device therapy dependent.Boston scientific technical services (ts) indicated that there was a previous stored episode in which the associated implantable cardioverter defibrillator (icd) device provided five (5) shocks for a true ventricular tachycardia (vt) and the shock impedance was 39 ohms for the delivered shocks.In addition, there was another stored episode that exhibited noise with a five (5) second pause in pacing therapy.The current rhythm was noted to be a normal sinus rhythm at a rate of 70 beats per minute (bpm), but the device is still pacing at the lower rate limit of 50 bpm.Ts indicating that it appears the lead is no longer sensing appropriately.Ts discussed with the boston scientific representative (rep) that they are concerned that there is a lead insulation breach, the patient should be considered unprotected and the lead needs to be replaced.The rv lead was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.The lead has been returned for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements were within normal limits, except the pressure test which failed due to a cut on the outer insulation which likely occurred during the explant procedure.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no additional anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11103720
• MDR Text Key: 224700342
• Report Number: 2124215-2020-24756
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526496981
• UDI-Public: 00802526496981
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2021
• Device Model Number: 0675
• Device Catalogue Number: 0675
• Device Lot Number: 502533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR