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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 Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  Injury  
Event Description
It was reported that this device was suspected of exhibiting premature battery depletion behavior.During the previous follow-up visit, interrogation showed that the device had reached end of life (eol).Six months prior, the estimated battery longevity showed 1.5 years remaining.At that time, the device appeared to be fully functional, and had not entered safety mode.Subsequently, this device was explanted and replaced.The new device was programmed the same as the previous device, and lead parameters were stable.No additional adverse patient effects were reported.This device is expected for return.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this device was suspected of exhibiting premature battery depletion behavior.During the previous follow-up visit, interrogation showed that the device had reached end of life (eol).Six months prior, the estimated battery longevity showed 1.5 years remaining.At that time, the device appeared to be fully functional, and had not entered safety mode.Subsequently, this device was explanted and replaced.The new device was programmed the same as the previous device, and lead parameters were stable.No additional adverse patient effects were reported.This device is expected for return.
 
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.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.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this device was suspected of exhibiting premature battery depletion behavior.During the previous follow-up visit, interrogation showed that the device had reached end of life (eol).Six months prior, the estimated battery longevity showed 1.5 years remaining.At that time, the device appeared to be fully functional, and had not entered safety mode.Subsequently, this device was explanted and replaced.The new device was programmed the same as the previous device, and lead parameters were stable.No additional adverse patient effects were reported.This device is expected for return.This report is being submitted to include updated device analysis results.
 
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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 Key16079716
MDR Text Key306450393
Report Number2124215-2022-55598
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 Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/20/2016
Device Model NumberK289
Device Catalogue NumberK289
Device Lot Number100550
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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