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

Model Number 3086

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Neck Pain (2433); Chest Tightness/Pressure (2463)

Event Date 01/30/2015

Event Type  Injury  

Event Description

It was reported during a trial procedure to implant the patient's lead, the physician noted a cerebrospinal fluid leak.It was also reported the patient experienced a headache.Follow-up information revealed the patient went to the er due to the patient experiencing an onset of new symptoms postoperative.The patient noted numbness in bilateral arm, increased headache, pain in neck and between shoulder blades, pressure in her chest, and frequent urination.Additional follow-up information revealed the patient's trial procedure ended as scheduled and the patient did not receive effective pain relief during the trial period.The patient's headache and additional symptoms resolved after the trial lead was removed.

Manufacturer Narrative

(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.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4546688
• MDR Text Key: 5527935
• Report Number: 1627487-2015-23101
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/28/2016
• Device Model Number: 3086
• Device Lot Number: 4591337
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 47 YR