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

Model Number	0276
Medical Device Problem Codes	Failure to Capture (1081); Failure to Read Input Signal (1581); Low impedance (2285); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
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 patient underwent an left ventricular assist device (lvad) procedure and presented to their health care facility for routine follow up post lvad procedure.Upon device interrogation, it was found that the right ventricular (rv) lead exhibited loss of capture, low r wave amplitudes and within range impedance measurements.It was noted that the patient has intermittent heart block with and underlying heart rate in the 60s.Additionally, device feature, right ventricular automatic threshold (rvat) had stopped taking measurements post lvad procedure.Technical services (ts) was consulted and provided troubleshooting and programming recommendations.An x-ray was recommended to assess device and lead placement.Subsequently, the device was reprogrammed during the office visit and the hcp was going to follow up with the implanting physician regarding next steps.At this time, the icd and the rv lead have been explanted at a surgical procedure.No additional adverse patient effects were reported.

• 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): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16760293
• Report Number: 2124215-2023-18209
• Device Sequence Number: 17687531
• Product Code: NVY
• UDI-Device Identifier: 00802526531231
• UDI-Public: 00802526531231
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: 2023
• 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
• Report Date (Section B): 04/18/2023

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: 07/08/2023
• Device Model Number: 0276
• Device Catalogue Number: 0276
• Device Lot Number: 425720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: 68 YR
• Patient Sex: Female