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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

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BOSTON SCIENTIFIC CORPORATION ACCOLADE EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L321
Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
Patient Problems Bradycardia (1751); Device Overstimulation of Tissue (1991)
Event Date 02/24/2024
Event Type  Injury  
Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient implanted with this pacemaker system experienced muscle stimulation and pacing pauses less than two seconds.It was determined that this pacemaker had entered safety mode.This pacemaker was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Device telemetry data determined it had undergone resets and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.
 
Event Description
It was reported that the patient implanted with this pacemaker system experienced muscle stimulation and pacing pauses less than two seconds.It was determined that this pacemaker had entered safety mode.This pacemaker was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.
 
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Brand Name
ACCOLADE EL DR
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 Key18871377
MDR Text Key337290236
Report Number2124215-2024-14447
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N970003/S167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/09/2017
Device Model NumberL321
Device Catalogue NumberL321
Device Lot Number704942
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/26/2024
Initial Date FDA Received03/08/2024
Supplement Dates Manufacturer Received05/14/2024
Supplement Dates FDA Received05/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0367-2018
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age78 YR
Patient SexMale
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