MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3086

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

Patient Problems Abscess (1690); Post Operative Wound Infection (2446)

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

The complaint of epidural abscess and suspected infection cannot be confirmed via laboratory testing.(b)(4).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 1 of 2.Reference mfr report #: 1627487-2015-07663.It was reported the patient had a trial procedure on (b)(6) 2015.Following the procedure, the patient experienced painful muscle spasms.As a result, the trial leads were removed on (b)(6) 2015.An mri was done and revealed an epidural abscess.Surgical intervention was taken to address the epidural abscess on (b)(6) 2015.The surgeon suspected it was an infection.The patient was then hospitalized on (b)(6) 2015.The patient is currently on antibiotics.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS 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
• MDR Report Key: 5246591
• MDR Text Key: 32030924
• Report Number: 1627487-2015-07662
• 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: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 3086
• Device Lot Number: 5229491
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2015
• 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): Hospitalization
• Patient Age: 51 YR