MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 4-CH DBS EXTENSION KIT, 50CM

Model Number 6315

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

Patient Problems Skin Erosion (2075); Post Operative Wound Infection (2446)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported the patient (b)(4) received a dbs system.The patient's right lead extension was eroding through his scalp.As a result, surgical intervention was undertaken in (b)(6) 2014 to explant the reported extension.However, the patient developed an infection at the erosion site.The physician cut part of the extension and left the rest implanted.The patient was rescheduled in (b)(6) 2015 to remove the remaining extension which was successful.The impedance readings through the right (new) and left extensions post surgery were in the normal range, and effective therapy has been restored.

Manufacturer Narrative

(b)(4).Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.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.

• Brand Name: 4-CH DBS EXTENSION KIT, 50CM
• Type of Device: DBS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, tx
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4586217
• MDR Text Key: 17208556
• Report Number: 1627487-2015-21078
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 6315
• Device Lot Number: 4215413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2013
• 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
• Treatment: MODEL 6010, BURR HOLE CAP; MODEL 6788, DBS IPG; MODEL 6315, DBS EXTENSION; MODEL 6149, DBS LEAD
• Patient Outcome(s): Other