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 Nausea (1970); Pain (1994); Vomiting (2144)

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.(b)(4).

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2015-20654.It was reported the patient experienced nausea, vomiting, and pain (date of event unknown) after scs permanent implant procedure and visited er.Later, the patient stated left leg could not be moved a few days after the perm procedure occurred.Additionally , the patient experienced a stroke and was taken to icu on (b)(6) 2015.As of (b)(6) 2015 the patient has regained some function in the left leg.

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.

Event Description

Further follow up received identified the patient was transfered to another hospital and still recovering through a blood clot in her leg.The patient has a history of blood clots.The physician implanted a filter to protect her from pulmonary embolism.

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.

Event Description

Further follow up received identified the patient is improving and has been discharged from the hospital.Additionally, the stroke was ischemic and that the patient has a history of clotting disorder.

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2015-20654.Additional follow up received identified the issue of nausea, vomiting and pain has resolved.Further the patient reported it was the hemorrhagic stroke.The patient is under the physician's observation.

• 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: 5247799
• MDR Text Key: 32088816
• Report Number: 1627487-2015-20653
• 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,Followup,Followup,Followup
• Report Date: 01/26/2016

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: 08/31/2017
• Device Model Number: 3186
• Device Lot Number: 5240613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2015; 01/04/2016; 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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