MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D003

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.(b)(4).

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded code 1005 indicative shorted shock on the right ventricular (rv) lead.Intervention was performed.The device was explanted and the right ventricular (rv) lead was capped.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Patient code 3191 captures the reportable event of additional surgical intervention.

• Brand Name: ORIGEN MINI ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9611917
• MDR Text Key: 175712656
• Report Number: 2124215-2019-28377
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526533761
• UDI-Public: 00802526533761
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

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 Date: 01/17/2019
• Device Model Number: D003
• Device Catalogue Number: D003
• Device Lot Number: 248343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 04/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR