MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL L; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4677

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009); No Apparent Adverse Event (3189)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported that left ventricular (lv) lead was an attempted implant due to product performance issue.The lead was never in service.No adverse patient effects were reported.

Manufacturer Narrative

The return of the product was requested.If the product is returned, product investigation will be performed, and this complaint would be updated upon analysis completion.

Event Description

It was reported that left ventricular (lv) lead was an attempted implant due to product performance issue.The lead was never in service.No adverse patient effects were reported.Additional information indicated that the lead was in place in a posterior lateral branch and when the physician cut away the whorly guide catheter, the catheter pulled back and the lead pulled back.The lead was unable to get into the branch again due to tortuous anatomy and a difficult coronary sinus.The lead was not at fault.A new lead was used at a different branch.

Manufacturer Narrative

The return of the product was requested.If the product is returned, product investigation will be performed, and this complaint would be updated upon analysis completion.This supplemental report was created to capture updates on h6: device codes and b5: describe event or problem.

• Brand Name: ACUITY X4 SPIRAL L
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 15485278
• MDR Text Key: 304412270
• Report Number: 2124215-2022-37924
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524592
• UDI-Public: 00802526524592
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4677
• Device Catalogue Number: 4677
• Device Lot Number: 830414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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 Age: 85 YR
• Patient Sex: Female