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

Model Number 3086

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fall (1848); Device Overstimulation of Tissue (1991); Shock from Patient Lead(s) (3162)

Event Date 08/27/2014

Event Type  Injury  

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2014-26765 follow up information identified the patient has lost movement on his left side after suffering a fall.The patient is currently using a walker.The cause of this issue is unknown.

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 1 of 2.Reference mfr report# : 1627487-2014-26765.It was reported the patient experienced a shocking sensation when his wife unhooked his trial cable from his leads.The patient reported he allegedly flew across the room landing on his buttocks and he then proceeded to get up and suffered a fall.The patient was reported to have sustained two pelvic fractures and was hospitalized for a couple of days.

Manufacturer Narrative

Sjm has limited info 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 (Section G): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston road; plano TX 75024
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4117653
• MDR Text Key: 6055368
• Report Number: 1627487-2014-26764
• 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,Followup
• Report Date: 06/22/2015

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: 06/01/2016
• Device Model Number: 3086
• Device Lot Number: 4651520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 09/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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): Hospitalization
• Patient Age: 83 YR