MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA AF MRI S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DDMC3D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Hematoma (1884); Transient Ischemic Attack (2109); Visual Impairment (2138); Weakness (2145); Discharge (2225)
Date of Event	11/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: 5076-52 lead, implanted: (b)(6) 2010.
Event or Problem Description
It was reported that post-operative of a device changeout, the patient developed a tia (transient ischemic attack) and was given anticoagulation medication (eliquis).Subsequently, the patient developed a pocket hematoma.The patient ultimately recovered and was discharged home with a small pocket hematoma.However, this progressed with the patient noted to have bloody discharge draining from the pocket incision site.The patient was given antibiotics empirically (bactroban and clindamycin).Three days later the patient was admitted and started on iv (intravenous) antibiotics.The pocket was revised with washout and hematoma evacuation.The event was considered resolved and the device remains in use.The event was noted to be related to the procedure.The patient was noted to be enrolled in the world-wide randomized antibiotic envelope infection prevention trial (wrap-it) study.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that shortly after awakening from anesthesia, the patient noted numbness and weakness of the left face, arms and legs.The patient also noted mild slurring of speech as well as a large visual defect in the left eye only, described as an "area of light out", which seemed to be somewhat central and eccentric to the left, which was causing a mild headache.

• Brand Name: EVERA AF MRI S
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6321015
• Report Number: 3004209178-2017-03484
• Device Sequence Number: 1251552
• Product Code: LWS
• UDI-Device Identifier: 00643169717244
• UDI-Public: 00643169717244
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/14/2018
• Device Model Number: DDMC3D1
• Device Catalogue Number: DDMC3D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: 11/23/2016; 06/04/2018
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/28/2017; 06/18/2018
• 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: 694765 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 72