MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN CRANIAL BURR HOLE COVER SYS.; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	6010
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sjm 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.Sjm defers to the patient's physician regarding medical history.
Event or Problem Description
Device 2 of 2.Reference mfr.Report#1627487-2017-04360.It was reported during dbs implant, the intracranial lead migrated due to improper securing of the lead by the guardian burr hole cover.Troubleshooting did not provide resolution.As a result, the physician opted to replace the burr hole cover.In turn, the case was completed.There was no known patient consequence.
Event or Problem Description
Additional information determined that this was the second stage of dbs implant, to place the ipg.At that time it was found that the original burr hole caps did not secure properly, leading to one of the leads to migrate.As a result, the existing burr hole caps were replaced, as well as a migrated lead "[manufacturer reference number: (b)(4)]".
Additional Manufacturer Narrative
H11: correction to b5: additional information determined that this was the second stage of dbs implant, to place the ipg.At that time, it was found that the original burr hole caps did not secure properly, leading to one of the leads migrate.As a result, the existing burr hole caps were replaced, as well as a migrated lead "[manufacturer reference number: (b)(4)]".Correction to d6a: (b)(6) 2017.Correction to d6b: (b)(6) 2017.

• Brand Name: GUARDIAN CRANIAL BURR HOLE COVER SYS.
• Common Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; +1(972)309-8000
• MDR Report Key: 6775738
• Report Number: 1627487-2017-04361
• Device Sequence Number: 19224583
• Product Code: MHY
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: Health Professional
• Device Expiration Date: 04/26/2019
• Device Model Number: 6010
• Device Lot Number: 5952747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DBS LEAD x 2
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male