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 Problems Impaired Healing (2378); Fluid Discharge (2686)

Event Date 08/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient received two scs trial extensions from the same lot number.Review of the patient's medical record identified the patient experienced complications with healing of the extensions surgical incision site during the trial period.The patient experienced drainage and bleeding at the extension wound site.The patient was evaluated by the physician two days after the trial procedure and was treated with antibiotics.On (b)(6) 2011 the physician determined there was no evidence of infection however the patient continued to report issues with wound healing.The patient was closely monitored.On (b)(6) 2011 the patient's wounds were determined to be healed and the extension leads were cut.The patient underwent his permanent scs implant procedure on (b)(6) 2011, at which time the remaining portions of the extensions were removed.

• 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: 5768979
• MDR Text Key: 48750145
• Report Number: 1627487-2016-03424
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: 3383
• Device Lot Number: 3422902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2011
• 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 3186 (X2), SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 82 YR