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

Model Number	D334VRM
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	10/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient received a shock and the device ¿read¿ anti-tachycardia pacing and delivered therapy.The patient was hospitalized, treated with medication, and released the following day.Approximately four months later, the patient presented to the emergency room after receiving fifteen inappropriate shocks for atrial fibrillation with rapid ventricular response.The patient was hospitalized, treated with medication and re-programming of the device was performed.The patient was discharged and the event was deemed resolved.The device remains in use.The patient is a participant in the product surveillance registry study.No further patient complications have been reported as a result of this event.

• Brand Name: PROTECTA 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: 6782220
• Report Number: 3004209178-2017-16941
• Device Sequence Number: 19232973
• Product Code: LWS
• UDI-Device Identifier: 00613994714626
• UDI-Public: 00613994714626
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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: 11/14/2014
• Device Model Number: D334VRM
• Device Catalogue Number: D334VRM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 108