MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 STRAIGHT; PACEMAKER

Model Number 4671

Device Problems Failure to Capture (1081); Difficult to Insert (1316); Defective Device (2588); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  Injury  

Event Description

It was reported that the left ventricular (lv) lead was presenting high capture thresholds measurements, loss of capture and a possible dislodgement.The lead was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information fields: b5 describe event or problem, h6 impact codes and device codes.

Event Description

It was reported that the left ventricular (lv) lead was presenting high capture thresholds measurements, loss of capture and a possible dislodgement.; the dislodgement was confirmed later on via fluoroscopy.The lead was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that the left ventricular (lv) lead is presenting high capture thresholds measurements, loss of capture and a possible dislodgement.The lead was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ACUITY X4 STRAIGHT
• Type of Device: PACEMAKER
• 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: 15608407
• MDR Text Key: 301775184
• Report Number: 2124215-2022-41470
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524516
• UDI-Public: 00802526524516
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S398
• 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,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2020
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 814317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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: 66 YR
• Patient Sex: Male