MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SECURA VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D204VRM
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient possibly received inappropriate shocks from their implantable cardioverter defibrillator (icd) for supra ventricular tachycardia (svt) versus vt/vf (ventricular tachycardia/ ventricular fibrillation).The icd remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported from information obtained from the clinic that the patient was seen and intervention was performed.

• Brand Name: SECURA VR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8925541
• Report Number: 3004209178-2019-16225
• Device Sequence Number: 11314373
• Product Code: LWS
• UDI-Device Identifier: 00613994714718
• UDI-Public: 00613994714718
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 02/14/2014
• Device Model Number: D204VRM
• Device Catalogue Number: D204VRM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6947M62 LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 54 YR