MAUDE Adverse Event Report: ABBOTT MEDICAL GUARDIAN CRANIAL BURR HOLE COVER SYSTEM; DBS BUR HOLE COVER

Model Number	6010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2021-02163, 1627487-2021-02165, and 1627487-2021-02166.It was reported that the patient experienced discomfort at the ipg and lead sites.Dr.Hebb revised the pocket multiple times with no resolution.As a result, the system was explanted on (b)(6) 2021.
Additional Manufacturer Narrative
The report of discomfort at the device site was not able to be confirmed.Discomfort or pain at the device site is commonly associated with patient anatomy and/or the location of the device; there is no testing for the returned device that can confirm this type of complaint.Visual and microscopic inspection of the devices found no anomalies that would have existed prior to explant that would have contributed to the alleged complaint.

• Brand Name: GUARDIAN CRANIAL BURR HOLE COVER SYSTEM
• Common Device Name: DBS BUR HOLE COVER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11666160
• Report Number: 1627487-2021-13218
• Device Sequence Number: 19567194
• Product Code: MHY
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 12/01/2018
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 5754317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/21/2021
• 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: MODEL 6172 LEAD; MODEL 6372 EXTENSION; MODEL 6660 IPG; MODEL 6172 LEAD; MODEL 6372 EXTENSION; MODEL 6660 IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Weight: 68