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

Model Number	DDBC3D4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.The initial reported event was received on (b)(6) 2018.Of note, the reportable serious injury of infection is normally submitted via an alternative summary report (asr) that would have been due on the submission date of 2018-07-31.Information was subsequently received on 2018-06-08 and revealed the event no longer qualifies for asr and is therefore being submitted as a 30-day report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient presented to the urgent care with a fever, an increase in pocket pain and swelling.Wound cultures and blood tests were positive for staphylococcus aureus.It was also reported the patient developed an infection of the left side of the pocket.The patient was treated with oral and intravenous antibiotics and the implantable cardioverter defibrillator system was removed.The patient is a participant in the product surveillance registry clinical 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.

• Brand Name: EVERA S DR
• 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: 7597562
• Report Number: 3004209178-2018-13336
• Device Sequence Number: 16473184
• Product Code: LWS
• UDI-Device Identifier: 00643169530294
• UDI-Public: 00643169530294
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 07/28/2018
• Device Model Number: DDBC3D4
• Device Catalogue Number: DDBC3D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 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: 6935M62 LEAD, 457453 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 93