MAUDE Adverse Event Report: ST. JUDE MEDICAL MTS SYSTEM

Model Number 3852

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Pain (1994); Paralysis (1997); Weakness (2145); Twitching (2172); Cramp(s) (2193); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388); Numbness (2415); Ambulation Difficulties (2544); Weight Changes (2607)

Event Date 07/29/2014

Event Type  Injury  

Event Description

In 2011, pt.Was injured at work where he slipped and fell on ice.Since then,pt.Has been having chronic back pain, which has been treated with pain medication.In (b)(6) 2014, pt.Had medtronic mts system installed for pain management.After surgery, pt.Became paralyzed in recovery for about 6 hours, which resulted into partial feeling in his legs.Pt.Spent a total of 3 days in icu and 4 days in the main hospital after surgery.Since then, pt.C/o extreme back pain, weakness/numbness/cramping/twitching in legs, ambulation difficulties, urinary/bowel movement problems, 40lb.Weight loss, and is practically bedridden.Pt.Has been hospitalized 2 additional times for back pain and seen has seen two different pain management groups for treatment.Pt.States the device is not working effectively and would like to know if there's any additional information fda can give him regarding this device and treatment.Pt.Also states, that workman's comp."doesn't believe" his claim of extreme back pain and says "it's all in my head".Workman's comp has referred him to a psychiatrist for evaluation.

• Brand Name: MTS SYSTEM
• Type of Device: MTS SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 4364759
• MDR Text Key: 5286733
• Report Number: MW5039795
• Device Sequence Number: 1
• Product Code: GZB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/22/2014

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: Other
• Device Model Number: 3852
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2014
• Patient Sequence Number: 1
• Patient Age: 51 YR