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

Model Number 0185

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Fall (1848)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this system with an implantable cardioverter defibrillator (icd), right ventricular (rv) and right atrial (ra) leads fell to the ground.A shock was delivered but a fault code 1004 related to short circuit was triggered.Also, a code 1006 regarding high voltage was triggered afterwards.External shocks were needed to convert the arrhythmia the patient was experiencing.The icd, ra and rv leads have been explanted at this time.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Type of Device: 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: 16551324
• MDR Text Key: 311369129
• Report Number: 2124215-2023-12406
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526531194
• UDI-Public: 00802526531194
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2009
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male