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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number 4675
Device Problems Positioning Problem (3009); No Apparent Adverse Event (3189)
Patient Problems Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2023
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
 
Event Description
It was reported that this left ventricular (lv) lead was not implanted successfully due to unknown product performance issue.This lead was never in service.No adverse patient effects were reported.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Correction to the initial mdr in blocks b5 and h6.This no longer apply as a reportable complaint as additional information indicated that the lead was attempted due to phrenic nerve stimulation caused by the patient's anatomy.Supplemental was submitted to capture additional information on b5: summary of event and h6: device code.
 
Event Description
It was reported that this left ventricular (lv) lead was not implanted successfully due to unknown product performance issue.This lead was never in service.No adverse patient effects were reported.Additional information received indicated that the lead was attempted due to phrenic nerve stimulation along the entire target branch and that the lead was attempted due to difficult to position.No adverse patient effects were reported.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Correction to the initial mdr in blocks b5 and h6.This no longer apply as a reportable complaint as additional information indicated that the lead was attempted due to phrenic nerve stimulation caused by the patient's anatomy.
 
Event Description
It was reported that this left ventricular (lv) lead was not implanted successfully due to unknown product performance issue.This lead was never in service.No adverse patient effects were reported.Additional information received indicated that the lead was attempted due to phrenic nerve stimulation along the entire target branch.No adverse patient effects were reported.
 
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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
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 Key17043405
MDR Text Key316349619
Report Number2124215-2023-27918
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526524578
UDI-Public00802526524578
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P010012/S398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4675
Device Catalogue Number4675
Device Lot Number823593
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age34 YR
Patient SexMale
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