MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 60CM; SCS EXTENSION

Model Number 3386

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/03/2016

Event Type  Injury  

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.(b)(4).

Event Description

Device 3 of 4.Reference mfr.Report# 1627487-2016-04376, reference mfr.Report# 1627487-2016-04377, reference mfr.Report# 1627487-2016-04379.It was reported the patient underwent surgical intervention on (b)(6) 2016 wherein the partial scs lead and the extensions left in-situ during the previous surgery (reference mfr.Report number: 1627487-2014-04008,1627487-2014-04153 and 1627487-2014-04154) were explanted and replaced.Additionally, it was reported the patient experienced drainage at the anchor site.Allegedly, the anchor was explanted about a month back (date unknown).Reportedly, effective stimulation was restored postoperatively.As of (b)(6) 2016 the drainage was resolved.

• Brand Name: EXTENSION, 60CM
• Type of Device: SCS EXTENSION
• 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
• MDR Report Key: 5903816
• MDR Text Key: 52984823
• Report Number: 1627487-2016-04378
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 3386
• Device Lot Number: 3808629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• 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 3788, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 61 YR