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

Model Number	0186
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scheduled device replacement surgical procedure, the existing dual coil right ventricular (rv) lead was connected to the new implantable cardioverter defibrillator (icd) device but exhibited high out of range shock impedance measurements greater than 200 ohms.The device was noted to be in the pocket when performing the measurements.Surrounding equipment was turned off to rule out any electromagnetic interference (emi).The rv lead was reconnected in the device header port two times.The physician noted that the lead terminal was tight in the device header port, but the lead terminal pin was visually confirmed to be past the connector block in the header, and the header set screws were secure.Continuing to troubleshoot, the physician then switched the high voltage rv lead terminal pins in the opposite device header ports.A vector breakdown was performed in both configurations and a shock impedance measurement of 45 ohms was observed in the rv lead distal coil to device can vector.This measurement is within normal specification limits.A second new icd device of the same model was attempted but with the same high out of range shock impedance results.Finally, the lead was reconnected to the original icd device again, and the shock impedance measurement was greater than 200 ohms.Boston scientific technical services (ts) suggested that based on the troubleshooting results, there may be an issue with the rv lead proximal coil and advised to program the rv lead to use only the distal shocking coil instead of both shocking coils.The new icd device was implanted, the existing rv lead remains in-service and the surgically procedure was successfully completed prior to pocket closure.No patient symptoms or 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 G
• 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: 13684635
• Report Number: 2124215-2022-04572
• Device Sequence Number: 14685049
• Product Code: LWS
• UDI-Device Identifier: 00802526531200
• UDI-Public: 00802526531200
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 06/15/2009
• Device Model Number: 0186
• Device Catalogue Number: 0186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male