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

Model Number	0263
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned and analysis will be performed, a supplemental medwatch will be filed if there is any further relevant information from that review.
Event or Problem Description
It was reported that this tachy lead was an attempted implant due to high pacing impedance.A possible fracture was noted where suture was tied down very tightly.The lead was never in service.No adverse patient effects.
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned and analysis will be performed, a supplemental medwatch will be filed if there is any further relevant information from that review.
Event or Problem Description
It was reported that this tachy lead was an attempted implant due to high pacing impedance.A possible fracture was noted where suture was tied down very tightly.The lead was never in service.No adverse patient effects.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12243409
• Report Number: 2124215-2021-21746
• Device Sequence Number: 17417584
• Product Code: NVY
• UDI-Device Identifier: 00802526601835
• UDI-Public: 00802526601835
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: 0263
• Device Catalogue Number: 0263
• Device Lot Number: 100330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR