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

Model Number 0185

Device Problem No Apparent Adverse Event (3189)

Patient Problems Twiddlers Syndrome (4563); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead was explanted due to unknown reasons.No additional information is available at the moment.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information: b5.Describe event or problem.H6.Impact codes and device codes.

Event Description

It was reported that this right ventricular (rv) lead was surgically abandoned due to the patient having twiddlers syndrome.No additional information is available at the moment.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: 16501493
• MDR Text Key: 310862564
• Report Number: 2124215-2023-10872
• 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,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2010
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2008
• 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: 82 YR
• Patient Sex: Female