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

Model Number	L221
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report will be updated when additional information is received.
Event or Problem Description
It was reported that during a routine device follow-up, this pacemaker showed a remaining longevity of 3 months.The device had only been implanted for three years, so premature battery depletion was suspected.Device data was submitted to technical services for review.Engineering analysis confirmed an abnormal increase in the power consumption and device replacement was recommended for within 90 days.No adverse patient effects were reported.The device remains implanted and in service, pending a replacement procedure.
Additional Manufacturer Narrative
This report will be updated when additional information is received.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a routine device follow-up, this pacemaker showed a remaining longevity of 3 months.The device had only been implanted for three years, so premature battery depletion was suspected.Device data was submitted to technical services for review.Engineering analysis confirmed an abnormal increase in the power consumption and device replacement was recommended for within 90 days.No adverse patient effects were reported.The device remains implanted and in service, pending a replacement procedure.The distributor representative later reported that the device had been explanted and replaced with a non-boston scientific product.The explanted device was not planned to be returned.

• Brand Name: PROPONENT EL DR
• Common Device Name: 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 Key: 11128078
• Report Number: 2124215-2020-27619
• Device Sequence Number: 631037
• Product Code: LWP
• UDI-Device Identifier: 00802526559112
• UDI-Public: 00802526559112
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/20/2017
• Device Model Number: L221
• Device Catalogue Number: L221
• Device Lot Number: 706875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown