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

Model Number 3186

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Seizures (2063); Inadequate Pain Relief (2388)

Event Date 04/19/2014

Event Type  Injury  

Event Description

Device 1 of 2 - reference mfr.Report 1627487-2014-21537; the patient received two scs leads with the same lot number.It was reported the patient experienced a seizure which resulted in a fall directly on the ipg site.The incident resulted in ineffective stimulation and per the patient, a change in the original pain pattern.The physician proceeded with a system in order to have an mri to evaluate the patient's pain pattern.

Manufacturer Narrative

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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston road; plano, TX 75024 ; 9725264823
• MDR Report Key: 4059241
• MDR Text Key: 22143916
• Report Number: 1627487-2014-21534
• 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: 07/19/2014

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: 12/01/2012
• Device Model Number: 3186
• Device Lot Number: 3269066
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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:
• Patient Outcome(s): Other
• Patient Age: 38 YR