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 Problem Death (1802)

Event Date 09/20/2017

Event Type  Death  

Manufacturer Narrative

St.Jude medical 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 3: reference mfr.Report: 1627487-2017-05972 and 3006705815-2017-01399.It was reported the patient underwent a surgical procedure where a scs system was implanted on (b)(6) 2017.The patient was placed under anesthesia and became unresponsive.The airway was obstructed and the patient was manually bagged; however, the patient did not resume breathing on her own.The patient was transported to the hospital and was pronounced deceased.The scs system was never turned on.Cause of death has not been reported by the physician.

Event Description

Device #2 of 3: reference mfr.Report: 1627487-2017-05972 and 3006705815-2017-01399 follow up information identified the cause of death is unknown.No autopsy was performed.The patient was dnr.The physician does not believe the scs system led to the death as there was no excessive bleeding or difficulty in placement of the devices.

• 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: tanja hoffman ; 6901 preston road; plano, TX 75024 ; 9723098520
• MDR Report Key: 6942808
• MDR Text Key: 89072197
• Report Number: 3006705815-2017-01398
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2019
• Device Model Number: 3186
• Device Lot Number: A000039177
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR