MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0292

Device Problems Pocket Stimulation (1463); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Undesired Nerve Stimulation (1980)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this (rv) lead was dislodged resulting in significant stimulation to this patient.It was noted there was vegetation on this lead so it will remain implanted in this pacemaker dependent patient.This patient also has a left ventricular (lv) lead.The physician was considering programming the rv all the way down so that this patient would not feel the stimulation.Technical services (ts) discussed the possibility of sensing concerns with the field representative and discussed options including turning this patients lv lead sensing off and increasing the lv output.It was noted that this patient is very sick and experienced previous numerous shocks due to a ventricular tachycardia (vt) storm.This rv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that this (rv) lead was dislodged resulting in significant stimulation to this patient.It was noted there was vegetation on this lead so it will remain implanted in this pacemaker dependent patient.This patient also has a left ventricular (lv) lead.The physician was considering programming the rv all the way down so that this patient would not feel the stimulation.Technical services (ts) discussed the possibility of sensing concerns with the field representative and discussed options including turning this patients lv lead sensing off and increasing the lv output.It was noted that this patient is very sick and experienced previous numerous shocks due to a ventricular tachycardia (vt) storm.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that this patient received a non boston scientific (bsc) pacemaker all while this rv lead, other leads and boston scientific device remain implanted.The non bsc device was placed for right atrial (ra) and rv pacing and the chronic bsc device is being used for defibrillation and left ventricular (lv) pacing.It was noted that this patient had experienced the aforementioned rv stimulation over the last year.It was noted that this patient is bacteremic.This rv lead remains in service.Additional information was received that this rv lead and device therapy were programmed off due to lead issues, and is now wearing a life vest.This rv lead remains implanted.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that this (rv) lead was dislodged resulting in significant stimulation to this patient.It was noted there was vegetation on this lead so it will remain implanted in this pacemaker dependent patient.This patient also has a left ventricular (lv) lead.The physician was considering programming the rv all the way down so that this patient would not feel the stimulation.Technical services (ts) discussed the possibility of sensing concerns with the field representative and discussed options including turning this patients lv lead sensing off and increasing the lv output.It was noted that this patient is very sick and experienced previous numerous shocks due to a ventricular tachycardia (vt) storm.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that this patient received a non boston scientific (bsc) pacemaker all while this rv lead, other leads and boston scientific device remain implanted.The non bsc device was placed for right atrial (ra) and rv pacing and the chronic bsc device is being used for defibrillation and left ventricular (lv) pacing.It was noted that this patient had experienced the aforementioned rv stimulation over the last year.It was noted that this patient is bacteremic.This rv lead remains in service.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 17939144
• MDR Text Key: 325725126
• Report Number: 2124215-2023-57097
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531248
• UDI-Public: 00802526531248
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/09/2019
• Device Model Number: 0292
• Device Catalogue Number: 0292
• Device Lot Number: 427123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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): Other
• Patient Age: 63 YR
• Patient Sex: Male