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

Model Number G051

Device Problems Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  Injury  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 305072131
• Report Number: 2124215-2022-51070
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization