MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE LEAD

Model Number	0148
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead triggered an alert for pacing lead impedance, high, out of range.There was noise on stored events in the past, that correspond to a surgical procedure.Programming options were discussed for this rv lead that remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead triggered an alert for pacing lead impedance, high, out of range.History shows gradual rise in impedance.There was noise on stored events in the past, that correspond to a surgical procedure.Programming options were discussed for this rv lead.Additional information was received mentioning that rv pacing thresholds were on the higher end as well and the physician elected to replace the lead with the patient being pacemaker dependent, therefore it was surgically abandoned.A lead fracture was assumed.The rv lead is not expected to be returned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead triggered an alert for pacing lead impedance, high, out of range.History shows gradual rise in impedance.There was noise on stored events in the past, that correspond to a surgical procedure.Programming options were discussed for this rv lead.Additional information was received mentioning that rv pacing thresholds were on the higher end as well and the physician elected to replace the lead with the patient being pacemaker dependent.A lead fracture was assumed.The rv lead is not expected to be returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19803062
• Report Number: 2124215-2024-45421
• Device Sequence Number: 8389000
• Product Code: LWS
• UDI-Device Identifier: 00802526085918
• UDI-Public: 00802526085918
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/25/2005
• Device Model Number: 0148
• Device Catalogue Number: 0148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 09/17/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/20/2024; 09/24/2024
• Date Device Manufactured: 11/25/2003
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male