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

Model Number	G051
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Ventricular Tachycardia (2132)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
This cardiac resynchronization therapy defibrillator (crt-d) and unknown model right ventricular (rv) lead declared fc1005 (shock to open conduction) from an out-of-range shock lead impedance greater than 145ohms.Boston scientific technical services reviewed the available data as initially the physician requested insight to shock therapy for the ventricular tachycardia (vt) episodes.It was confirmed that the most recent shock therapy delivered was within normal shock impedance range.Additionally, the biv triggered pace cannot be exclude from contributing to any of the given arrhythmias, however the biv trigger might also have been triggered by an arrhythmic ventricular event.It is suspected the lead system is damaged or disconnected.The physician has reprogrammed the device.The device remain in service.No adverse patient effects were reported.

• 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
• MDR Report Key: 10707912
• Report Number: 2124215-2020-21152
• Device Sequence Number: 3644592
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/15/2019
• Device Model Number: G051
• Device Catalogue Number: G051
• Device Lot Number: 122827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1