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

Model Number 4674

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Internal Organ Perforation (1987); Pneumothorax (2012)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during implant, this cardiac resynchronization therapy defibrillator (crt-d) perforated the patient's lungs.Moreover, the patient was supposed to be hospitalized for overnight only however, turned into a ten day stay.As of this time, this device remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that during implant, this cardiac resynchronization therapy defibrillator (crt-d) perforated the patient's lungs.Moreover, the patient was supposed to be hospitalized for overnight only however, turned into a ten day stay.As of this time, this device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.This report is being filed to correct the h6: patient codes.

• Brand Name: ACUITY X4 SPIRAL S
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12221686
• MDR Text Key: 263365810
• Report Number: 2124215-2021-20747
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 519988
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR