MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 0.5

Model Number 6149

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Event Description

It was reported a patient with a dbs system underwent a surgical procedure due to a skin erosion close to the dbs lead in the left side.A swab test was done with negative results.A section of a skin from the head was removed and grafted over the erosion.The dbs system was on before and after surgical revision.The patient remained at the hospital and under monitoring.Follow up information received identified the patient was well.She is visited every week to see the progression of the skin over the burr hole cover.

Event Description

Additional information received identified the patient's issue of skin erosion has been addressed and resolved.

• Brand Name: 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 0.5
• Type of Device: DBS LEAD
• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8516988
• MDR Text Key: 142031170
• Report Number: 1627487-2019-04627
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other