MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G051
Medical Device Problem Codes	Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was unable to be interrogated with the 3300 programmer nor with the 3120 programmer.There were no beeps tones with the magnet and the pacing rate were at 60 bpm.Additionally, the device was suspected of premature battery depletion.The patient was hospitalized and subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was unable to be interrogated with the 3300 programmer nor with the 3120 programmer.There were no beeps tones with the magnet and the pacing rate were at 60 bpm.Additionally, the device was suspected of premature battery depletion.The patient was hospitalized and subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.Additionally, new corrected information was provided on (b)(6) 2022.It was reported that the 3300 programmer was unable to interrogate the patient's device since it was not a boston scientific device but a competitor device.This patient no longer had a boston scientific device since it was explanted/replaced in croatia.This new information refutes the allegation of premature battery depletion and unable to interrogate issue.It was not known when the replacement occurred, and there had been no malfunction allegation against this boston scientific device model g051.No additional adverse patient effects were reported, and the competitor device remains in-service.No further information is available.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

• Brand Name: ORIGEN CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 15940942
• Report Number: 2124215-2022-51070
• Device Sequence Number: 15051628
• Product Code: NIK
• UDI-Device Identifier: 00802526534478
• UDI-Public: 00802526534478
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2022

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: 09/07/2018
• Device Model Number: G051
• Device Catalogue Number: G051
• Device Lot Number: 117998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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