MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Paralysis (1997); Weakness (2145)

Event Date 08/29/2017

Event Type  Injury  

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

Device 3 of 3.Reference mfr.Report# 1627487-2017-05426.Reference mfr.Report# 3006705815-2017-01275.It was reported the patient was admitted to the hospital for having stroke with symptoms of weakness, slurred speech and loss of mobility in left side.The physician doesn¿t believe the issue was related to the device or to the procedure.As per physician the patient stopped the blood thinner for five days which may have been a possible cause of stroke.The patient medication has changed and is in rehabilitation center and is improving.

Event Description

Device 3 of 3.Reference mfr.Report# 1627487-2017-05426.Reference mfr.Report# 3006705815-2017-01275.Additional information received identified the patient is discharged from the rehabilitation center.As of (b)(6) 2017 the patient was talking and eating some by her own.However the patient has not gained movement.

Event Description

Device 3 of 3: reference mfr.Report# 1627487-2017-05426; reference mfr.Report# 3006705815-2017-01275.Additional information received identified the patient is recovering and is confined to a wheelchair.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: taruna sharma ; 6901 preston road; plano, TX 75024 ; 9725269635
• MDR Report Key: 6890236
• MDR Text Key: 87205673
• Report Number: 3006705815-2017-01276
• 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,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2019
• Device Model Number: 3186
• Device Lot Number: A000040486
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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): Hospitalization
• Patient Age: 73 YR