MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3186

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Muscle Weakness (1967); Headache, Lumbar Puncture (2186)

Event Date 02/18/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2014-26205.It was reported during a lead revision surgery, the pt suffered a csf leak.It was reported the pt was asymptomatic in post-op.F/u info identified the pt received a blood patch and was hospitalized for 2 nights due to headache and numbness in buttocks and legs.F/u info identified the headache is much better and leg numbness was almost gone.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3692803
• MDR Text Key: 4254495
• Report Number: 1627487-2014-26206
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: 3186
• Device Lot Number: 4387143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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: SCS ANCHOR: MODEL 1192 (2); IMPLANT DATE:; SCS IPG: MODEL 3788; IMPLANT DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR