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

Model Number 3186

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

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

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

The complaint of epidural abscess and septic 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.Udi (di): (b)(4).

Event Description

Device 1 of 2.Reference mfr report #: 1627487-2015-07668.It was reported the patient had a scs permanent lead implant procedure on (b)(6) 2015 and had the ipg implanted on (b)(6) 2015.Following the second implant procedure, the patient went to the emergency room due to post-implant complications.Blood test was done without specific findings.A few days later, the patient became unconscious and it was determined via further testing that the patient had an epidural abscess with a septic infection.The patient was hospitalized.Follow-up revealed the patient had paralysis and was in coma.As a result, the patient's scs system was explanted.The explant date is unknown.

• Brand Name: OCTRODE 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: 5246764
• MDR Text Key: 32036495
• Report Number: 1627487-2015-07667
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 3186
• Device Lot Number: 5190427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2015
• 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
• Treatment: MODEL: 1192 (X2), SCS ANCHORS
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR