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

Model Number 3228

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

Patient Problems Hematoma (1884); Neurological Deficit/Dysfunction (1982); Blood Loss (2597)

Event Date 04/17/2015

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report:1627487-2015-03178.The patient reported the day after implant he experienced difficulty sitting up and subsequently was unable to move his legs.The patient also reported experiencing cramping in his back.As a result, the patient was admitted to the hospital (intensive care unit) and the scs system was explanted.Moreover, it was reported the patient experienced a total loss of motor and sensory function from t7 down and had multiple clots and as of (b)(6) 2015, epidural and pocket site hematomas (pressure/bleeding) were confirmed.As a result, the patient underwent multiple surgeries between (b)(6) 2015.The patient had regained a small amount of feeling in his legs.Additionally, as of (b)(6) 2015, the patient had regained a small amount of movement in one foot.As of (b)(6) 2015, the patient has been transferred to a spinal rehab facility and has started to regain more motor and sensory function although he is still unable to bear weight.

Event Description

Device 1 of 2 reference mfr.Report#: 1627487-2015-03178 follow-up/additional information gathered revealed a cerebrospinal fluid leak has occurred.The cause is unknown.As a result, the patient underwent an exploratory surgical procedure on (b)(6) 2015 to possibly address the issue.The patient's doctor has decided not to share further details.It was also reported the patient is now walking, doing better, and continuing to make progress.

Manufacturer Narrative

Udi(di): (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.

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.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4754076
• MDR Text Key: 5825130
• Report Number: 1627487-2015-03177
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 3228
• Device Lot Number: 4921449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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; Required Intervention
• Patient Age: 61 YR