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

Model Number	D204DRM
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was inappropriately shocked by the implantable cardioverter defibrillator (icd) for supra ventricular tachycardia (svt) the device had detected as ventricular tachycardia (vt).Follow-up was attempted with the physician; however, no additional information could be obtained.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: SECURA DR
• 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: 6920365
• Report Number: 3004209178-2017-20858
• Device Sequence Number: 16316581
• Product Code: LWS
• UDI-Device Identifier: 00613994714695
• UDI-Public: 00613994714695
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 08/21/2017

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: 09/14/2013
• Device Model Number: D204DRM
• Device Catalogue Number: D204DRM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 10/06/2017
• 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, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 54 YR