MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0672

Device Problems Mechanical Problem (1384); Contamination /Decontamination Problem (2895); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The electrode end damage allegation was confirmed based on the observation of a deformed helix (bent).On the other hand, dislodgement was not confirmed with evidence from the field and product analysis were insufficient to verify dislodgement.Further, continuity testing was passed indicating conductors were intact.

Event Description

It was reported that this right ventricular (rv) lead was an attempted implant due to dislodgement.Also, the lead screw would not extend or retract and it was noted that there was a tissue in the screw mechanism.Further, the physician damaged the screw during the attempt to clear the tissue from the screw.The lead was never in service.No adverse patient effects were reported.

Event Description

It was reported that this right ventricular (rv) lead was an attempted implant due to dislodgement.Also, the lead screw would not extend or retract and it was noted that there was a tissue in the screw mechanism.Further, the phsyician damaged the screw during the attempt to clear the tissue from the screw.The lead was never in service.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The contamination, dislodgement allegations were not confirmed by analysis as there was no tissue noted entwined in the helix and evidence from the field/product analysis were insufficient to verify dislodgement.On the other hand, the allegation of helix extention/extraction difficulty was confirmed based on the observation of a deformed helix.Also, the prolonged surgery based on the observation of the helix bent.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12218758
• MDR Text Key: 263186260
• Report Number: 2124215-2021-20491
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592829
• UDI-Public: 00802526592829
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 108061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR