MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

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

Patient Problem Fluid Discharge (2686)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2018-00929.It was reported clear drainage was present at the location of the patient's extensions during their scs trial term.The extensions were removed as planned for the trial period.Afterwards, a permanent scs system was implanted without issue.The patient will be placed on oral antibiotics in the meantime.

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2018-00929.Follow-up revealed the patient's issue has resolved.

• Brand Name: EXTENSION, 30CM
• 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: 7229374
• MDR Text Key: 98625911
• Report Number: 1627487-2018-00928
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2019
• Device Model Number: 3383
• Device Lot Number: 6048178
• Other Device ID Number: 05414734402323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• 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
• Patient Age: 71 YR