MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN CRANIAL BURR HOLE COVER SYS.; DBS ACCESSORY

Model Number	6010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
Device 6 of 7, reference mfr.Report #: 1627487-2018-06345, reference mfr.Report #: 1627487-2018-06346, reference mfr.Report #: 1627487-2018-06347, reference mfr.Report #: 1627487-2018-06348, reference mfr.Report #: 1627487-2018-06349, reference mfr.Report #: 1627487-2018-06351.It was reported the patient experienced an infection at the ipg and lead sites.As a result, the physician explanted the dbs system.Additional information has been requested but not yet received.
Event or Problem Description
Device 6 of 7, reference mfr.Report #: 1627487-2018-06345, reference mfr.Report #: 1627487-2018-06346, reference mfr.Report #: 1627487-2018-06347, reference mfr.Report #: 1627487-2018-06348, reference mfr.Report #: 1627487-2018-06349, reference mfr.Report #: 1627487-2018-06351.Follow up information identified the physician admitted the patient to the hospital and administered iv antibiotics for (b)(6).Further information revealed the patient was re-admitted to the hospital for continued treatment of the ongoing infection.
Event or Problem Description
Device 6 of 7: reference mfr.Report #: 1627487-2018-06345; reference mfr.Report #: 1627487-2018-06346; reference mfr.Report #: 1627487-2018-06347; reference mfr.Report #: 1627487-2018-06348; reference mfr.Report #: 1627487-2018-06349; reference mfr.Report #: 1627487-2018-06351.Follow up information identified the patient¿s infection is believed to be resolved, but the patient continues treatment as the skin has eroded and the skull is exposed.The patient has been referred to a plastic surgeon for further treatment.

• Brand Name: GUARDIAN CRANIAL BURR HOLE COVER SYS.
• Common Device Name: DBS ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7674907
• Report Number: 1627487-2018-06350
• Device Sequence Number: 16496290
• Product Code: GXR
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152342
• 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,Followup
• Report Date (Section B): 09/07/2018

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: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 6231576
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 08/20/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/15/2018; 09/07/2018
• 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; Other