MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; Implantable Load

Model Number	0148
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2009
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific crm received information that this right ventricular (rv) defibrillation lead exhibited high pace impedance >2000 ohms.Impedance had been rising from approximately 1800 ohms in november to >2000 ohms now.No adverse patient effects have been reported.Additional information indicated that the lead continues to have high pacing impedance measurements.The physician is aware of these measurements and has decided to monitor the patient at this time.
Event or Problem Description
Boston scientific crm received information that this right ventricular (rv) defibrillation lead exhibited high pace impedance >2000 ohms.Impedance had been rising from approximately 1800 ohms in november to >2000 ohms nsrli.No adverse patient effects have been reported.
Event or Problem Description
Boston scientific crm received information that this right ventricular (rv) defibrillation lead exhibited high pace impedance >2000 ohms.Impedance had been rising from approximately 1800 ohms in november to >2000 ohms now.No adverse patient effects have been reported.
Additional Manufacturer Narrative
All available information indicates that the lead remains in service.A boston scientific representative was contacted but was unable to provide any additional information.It was later reported that alerts continued for the high rv pace impedance.The physician was aware of the situation and has decided to monitor the patient at this lime.The physician did not want further notification of these alerts.There is no additional information available.If additional information becomes available this event will be updated.
Additional Manufacturer Narrative
All available information indicates that the lead remains in service.A boston scientific representative was contacted but was unable to provide any additional information.Ii was later reported that alerts continued for the high rv pace impedance.The physician was aware of the situation and did not want further notification of these alerts.There is no additional information available.If additional information becomes available this even! will be updated.
Additional Manufacturer Narrative
All available information indicates that the lead remains in service.A boston scientific representative was contacted but was unable to provide any additional information.It was later reported that alerts continued for the high rv pace impedance.The physician was aware of the situation and did not want further notification of these alerts.There is no additional information available.If additional information becomes available this event will be updated.This follow-up 001 report was not submitted previously.As per request by the fda on june 16, 2026 follow-up 001 has been resubmitted in an effort to release follow-up 002 from hold status.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: Implantable Load
• 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.; dorado, pr 00646 ; PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; 55112.; guidant puerto rico b.; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50862154
• Report Number: 2124215-2009-00575
• Device Sequence Number: 10725706
• Product Code: LWS
• UDI-Device Identifier: 00802526085918
• UDI-Public: (01)00802526085918(17)040803
• Combination Product (Y/N): Y
• Initial Reporter Country: NO
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2010

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: Lay User/Patient
• Device Expiration Date: 08/03/2004
• Device Model Number: 0148
• Device Catalogue Number: 0148
• Device Lot Number: 0148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Received by Manufacturer: 01/11/2009
• Supplement Date Received by Manufacturer: 03/23/2010; 01/11/2009
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/23/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2002
• 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
• Patient Age: 73 YR
• Patient Sex: Female