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

Model Number	4593
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661); Migration (4003)
Health Effect - Clinical Codes	Syncope/Fainting (4411); Twiddlers Syndrome (4563)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited oversensing due to noise with high within range pacing impedance measurements.In addition, one inappropriate burst of anti-tachycardia pacing (atp) was delivered.The patient experienced a large amount of weight loss, as a result this cardiac resynchronization therapy defibrillator (crt-d) migrated and was unstable in pocket.However, the patient had manipulated the device causing noise recorded.The rv lead exhibited variable high within range pacing impedance measurements.Isometric tests were performed, and measurements were in range.The patient declined the device relocation and remains under monitoring.No adverse patient effects were reported.This rv lead remains in service.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited oversensing due to noise with high within range pacing impedance measurements.In addition, one inappropriate burst of anti-tachycardia pacing (atp) was delivered.The patient experienced a large amount of weight loss, as a result this cardiac resynchronization therapy defibrillator (crt-d) migrated and was unstable in pocket.However, the patient had manipulated the device causing noise recorded.The rv lead exhibited variable high within range pacing impedance measurements.Isometric tests were performed, and measurements were in range.The patient declined the device relocation and remains under monitoring.No adverse patient effects were reported.This rv lead remains in service.It was reported that this rv lead exhibited oversensing due to noise with pacing inhibition, resulting in inappropriate anti-tachycardia pacing (atp) and syncope.Rv lead pacing impedance was also fluctuating by 900 ohms every few days with out-of-range measurements observed.Undersensing was also noted.The patient was admitted to the hospital for a cardiology consult and to potentially replace the rv lead.The rv lead remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited oversensing due to noise with high within range pacing impedance measurements.In addition, one inappropriate burst of anti-tachycardia pacing (atp) was delivered.The patient experienced a large amount of weight loss, as a result this cardiac resynchronization therapy defibrillator (crt-d) migrated and was unstable in pocket.However, the patient had manipulated the device causing noise recorded.The rv lead exhibited variable high within range pacing impedance measurements.Isometric tests were performed, and measurements were in range.The patient declined the device relocation and remains under monitoring.No adverse patient effects were reported.This rv lead remains in service.It was reported that this rv lead exhibited oversensing due to noise with pacing inhibition, resulting in inappropriate anti-tachycardia pacing (atp) and syncope.Rv lead pacing impedance was also fluctuating by 900 ohms every few days with out-of-range measurements observed.Undersensing was also noted.The patient was admitted to the hospital for a cardiology consult and to potentially replace the rv lead.The rv lead remains in service.No additional adverse patient effects were reported.Additional information was received, this rv lead was tested at office and there were no signs of lead fracture.This rv lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Correction: h6: absence of treatment.
Additional Manufacturer Narrative
This report is being submitted to update section b5 and h6 codes.Prv.Correction: h6: absence of treatment.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited oversensing due to noise with high within range pacing impedance measurements.In addition, one inappropriate burst of anti-tachycardia pacing (atp) was delivered.The patient experienced a large amount of weight loss, as a result this cardiac resynchronization therapy defibrillator (crt-d) migrated and was unstable in pocket.However, the patient had manipulated the device causing noise recorded.The rv lead exhibited variable high within range pacing impedance measurements.Isometric tests were performed, and measurements were in range.The patient declined the device relocation and remains under monitoring.No adverse patient effects were reported.This rv lead remains in service.It was reported that this rv lead exhibited oversensing due to noise with pacing inhibition, resulting in inappropriate anti-tachycardia pacing (atp) and syncope.Rv lead pacing impedance was also fluctuating by 900 ohms every few days with out-of-range measurements observed.Undersensing was also noted.The patient was admitted to the hospital for a cardiology consult and to potentially replace the rv lead.The rv lead remains in service.No additional adverse patient effects were reported.Additional information was received, this rv lead was tested at office and there were no signs of lead fracture.This rv lead remains in service.No additional adverse patient effects were reported.Additional information indicated that this rv lead was surgically abandoned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited oversensing due to noise with high within range pacing impedance measurements.In addition, one inappropriate burst of anti-tachycardia pacing (atp) was delivered.The patient experienced a large amount of weight loss, as a result this cardiac resynchronization therapy defibrillator (crt-d) migrated and was unstable in pocket.However, the patient had manipulated the device causing noise recorded.The rv lead exhibited variable high within range pacing impedance measurements.Isometric tests were performed, and measurements were in range.The patient declined the device relocation and remains under monitoring.No adverse patient effects were reported.This rv lead remains in service.It was reported that this rv lead exhibited oversensing due to noise with pacing inhibition, resulting in inappropriate anti-tachycardia pacing (atp) and syncope.Rv lead pacing impedance was also fluctuating by 900 ohms every few days with out-of-range measurements observed.Undersensing was also noted.The patient was admitted to the hospital for a cardiology consult and to potentially replace the rv lead.The rv lead remains in service.No additional adverse patient effects were reported.Additional information was received, this rv lead was tested at office and there were no signs of lead fracture.This rv lead remains in service.No additional adverse patient effects were reported.Additional information indicated that this rv lead was surgically abandoned.No additional adverse patient effects were reported.The complaint device was not returned to bsc, therefore product analysis could not be performed.The primary reported observation is addressed in product labeling (e.G.Instructions for use).Therefore, well-understood factors likely contributed to the event.
Additional Manufacturer Narrative
This report is being submitted to update section b5 and h6 codes.Prv correction: h6: absence of treatment this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of labeling determined that the complaint situation was listed in the manual.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of failure to follow instruction.

• Brand Name: ACUITY? SPIRAL
• Common Device Name: IMPLANTABLE 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: 20216802
• Report Number: 2124215-2024-57434
• Device Sequence Number: 18117850
• Product Code: LWP
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/16/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2014
• Device Model Number: 4593
• Device Catalogue Number: 4593
• Device Lot Number: 108928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 11/04/2024; 02/05/2026; 06/15/2026
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/31/2024; 11/11/2024; 02/12/2026; 06/16/2026
• Date Device Manufactured: 08/29/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Female