MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY SPIRAL; IMPLANTABLE LEAD

Model Number 4591

Device Problems Failure to Capture (1081); Defective Device (2588); No Apparent Adverse Event (3189)

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

Event Date 12/06/2022

Event Type  Injury  

Event Description

It was reported that this lead was surgically abandoned due to unknown product performance issues.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 lead insulation became damaged during the procedure and a lead presenting failure to capture.The lead was capped, and a new lead was implanted.No additional information is available at the moment.No additional adverse patient effects were reported.

• Brand Name: ACUITY SPIRAL
• 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: 16014104
• MDR Text Key: 305795310
• Report Number: 2124215-2022-53738
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S160
• 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: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2010
• Device Model Number: 4591
• Device Catalogue Number: 4591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2008
• 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: 62 YR
• Patient Sex: Female