MAUDE Adverse Event Report: ST. JUDE MEDICAL NEUROMODULATION DIVISION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

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

Patient Problems Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982)

Event Date 11/05/2015

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.

Event Description

It was reported the patient underwent surgical intervention to have a cervical placement of a lead on (b)(6) 2015 it was reported the patient experienced decreased function in both arms and hands.The patient has regained more function in his left hand than the right hand and in addition, he is experiencing allodynia in both arms.It is unknown when this loss of function occurred as postoperatively the patient had full function of his arms and hands.Follow up information identified the patient has regained some mobility in his arms and hands bilaterally.The patient has been prescribed physical and occupational therapy.Reprogramming was able to provide stimulation in arms and hands bilaterally.Further reprogramming may be pending.

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

Follow up information identified the patient has not regained full range of motion in either arm but in improving.The patient is receiving effective stimulation and is continuing physical therapy.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston road; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston road; plano TX 75024
• MDR Report Key: 5255574
• MDR Text Key: 32340518
• Report Number: 1627487-2015-26650
• 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
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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: 3228
• Device Lot Number: 5222331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2015
• 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
• Patient Age: 43 YR