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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number J177
Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Human-Device Interface Problem (2949); Inappropriate or Unexpected Reset (2959); Data Problem (3196)
Patient Problems Dyspnea (1816); Asystole (4442)
Event Date 07/25/2023
Event Type  Injury  
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
It was reported that during a routine device interrogation when the physician placed the wand over the pacemaker, a few seconds later the patient was gasping for air and pacing inhibition with approximately 15 seconds asystole was observed.After the episode, the physician was able to interrogate the pacemaker successfully without problems.Technical services (ts) was consulted and discussed the possibility of a reset occurring at wand placement due to increased power requirement because of the interrogation.Ts suggested replacing the pacemaker without any further interrogation attempts.Subsequently a revision procedure was performed where the pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.Post explant, the field representative attempted to interrogate the device to retrieve information regarding implant date and lead information, however all the fields were blank.The physician's office did not have the information in their medical records.The patient noted they had this pacemaker implanted for 10 years.
 
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
It was reported that during a routine device interrogation when the physician placed the wand over the pacemaker, a few seconds later the patient was gasping for air and pacing inhibition with approximately 15 seconds asystole was observed.After the episode, the physician was able to interrogate the pacemaker successfully without problems.Technical services (ts) was consulted and discussed the possibility of a reset occurring at wand placement due to increased power requirement because of the interrogation.Ts suggested replacing the pacemaker without any further interrogation attempts.Subsequently a revision procedure was performed where the pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.Post explant, the field representative attempted to interrogate the device to retrieve information regarding implant date and lead information, however all the fields were blank.The physician's office did not have the information in their medical records.The patient noted they had this pacemaker implanted for 10 years.Additional information was received from the clinic that the pacemaker was likely in safety mode at the time of interrogation attempts.
 
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and had undergone resets.The system resets occurred during a telemetry session and caused the device to enter safety mode.This contributed to the pacing inhibition seen in the fieldengineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
 
Event Description
It was reported that during a routine device interrogation when the physician placed the wand over the pacemaker, a few seconds later the patient was gasping for air and pacing inhibition with approximately 15 seconds asystole was observed.After the episode, the physician was able to interrogate the pacemaker successfully without problems.Technical services (ts) was consulted and discussed the possibility of a reset occurring at wand placement due to increased power requirement because of the interrogation.Ts suggested replacing the pacemaker without any further interrogation attempts.Subsequently a revision procedure was performed where the pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.Post explant, the field representative attempted to interrogate the device to retrieve information regarding implant date and lead information, however all the fields were blank.The physician's office did not have the information in their medical records.The patient noted they had this pacemaker implanted for 10 years.Additional information was received from the clinic that the pacemaker was likely in safety mode at the time of interrogation attempts.The device was returned for analysis.
 
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Brand Name
INGENIO
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 Key17553352
MDR Text Key321220498
Report Number2124215-2023-43724
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 12/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/24/2015
Device Model NumberJ177
Device Catalogue NumberJ177
Device Lot Number100745
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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