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

Model Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

The reported event cannot be analyzed via laboratory testing.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.

Event Description

It was reported the patient experienced a headache due to a cerebrospinal fluid leakage during the trial procedure on (b)(6) 2017.As a result, a blood patch was performed as the next course of action.

Event Description

Follow-up identified the issue resolved.

• 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: 6667925
• MDR Text Key: 78422528
• Report Number: 1627487-2017-03425
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 41 YR