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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FORMIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION FORMIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number K289
Device Problems High impedance (1291); Over-Sensing (1438)
Patient Problems Dyspnea (1816); Tachycardia (2095)
Event Date 12/01/2021
Event Type  Injury  
Event Description
It was reported that this pacemaker and right atrial (ra) had triggered a lead safety switch due to high pacing impedances measurements, measuring greater than 2,500 ohms along with noise.It was suspected that the ra lead had fracture.It was believed that the patient had elevated heart rate often due to the minute ventilation (mv) feature and the patient also experienced shortness of breath.The mv was programmed to auto-select for the mv vector.The patient was admitted into the hospital for a lead revision and box change.Subsequently, the ra lead was capped/abandoned left in-situ, a new ra lead was implanted and the pulse generator was explanted and replaced.No additional adverse patient effects were reported.
 
Event Description
It was reported that this pacemaker and right atrial (ra) had triggered a lead safety switch due to high pacing impedances measurements, measuring greater than 2,500 ohms along with noise.It was suspected that the ra lead had fracture.It was believed that the patient had elevated heart rate often due to the minute ventilation (mv) feature and the patient also experienced shortness of breath.The mv was programmed to auto-select for the mv vector.The patient was admitted into the hospital for a lead revision and box change.Subsequently, the ra lead was capped/abandoned left in-situ, a new ra lead was implanted and the pulse generator was explanted and replaced.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gage testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the b5 describe event or problem for more information regarding the specific circumstances of this event.
 
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Brand Name
FORMIO
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
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key14131994
MDR Text Key289433771
Report Number2124215-2022-11389
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/09/2017
Device Model NumberK289
Device Catalogue NumberK289
Device Lot Number101572
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age84 YR
Patient SexMale
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