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 Fall (1848); Seizures (2063)

Event Type  Injury  

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.

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2016-04322.It was reported the patient has been experiencing seizure activity and as a result has suffered multiple falls.The patient underwent surgical intervention to explant the entire scs system on (b)(6) 2016.The stimulation was turned on during the first seizure and it is unknown if the scs system was turned on during the second seizure.The patient has no history of seizure activity and the physician does not believe the seizure activity is related to the scs system.

• 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: 5893851
• MDR Text Key: 52668979
• Report Number: 1627487-2016-04323
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 3186
• Device Lot Number: 3097023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2010
• 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: MODEL 1192(2), SCS ANCHOR
• Patient Outcome(s): Other