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

Model Number 0273

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (4563)

Event Date 09/13/2023

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited oversensing of atrial signals leading to double counting of the rate and resulting in a single burst of anti-tachycardia pacing (atp) given.Boston scientific technical services (ts) was consulted and further evaluation was recommended to determine the right ventricular (rv) lead position.Additional information was received that undersensing and loss of capture (loc) were also observed.A chest x ray confirmed a lead dislodgement and was suspected to be due to twiddler syndrome.A revision procedure was performed and this lead was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This lead was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Damage to the lead was noted.Due to the location and morphology of damage to the lead it is likely that external stress applied to the lead body resulted in the clinical observations.Past experience suggests patient manipulation of the lead through the skin (i.E., twiddler's syndrome) is a contributing factor to damage of this type.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited oversensing of atrial signals leading to double counting of the rate and resulting in a single burst of anti-tachycardia pacing (atp) given.Boston scientific technical services (ts) was consulted and further evaluation was recommended to determine the right ventricular (rv) lead position.Additional information was received that undersensing and loss of capture (loc) were also observed.A chest x ray confirmed a lead dislodgement and was suspected to be due to twiddler syndrome.A revision procedure was performed and this lead was explanted and replaced.No additional adverse patient effects were reported.This lead has been received for analysis.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: 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: 17830886
• MDR Text Key: 324431290
• Report Number: 2124215-2023-53221
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526601811
• UDI-Public: 00802526601811
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 0273
• Device Catalogue Number: 0273
• Device Lot Number: 123202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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: 58 YR
• Patient Sex: Female