MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3286

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Neurological Deficit/Dysfunction (1982); Paresis (1998); Numbness (2415)

Event Date 02/05/2015

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2015-05090.

Manufacturer Narrative

Results the reported neurological deficit experienced by the patient could not be confirmed by product testing alone.The lead was returned without any visible anomalies that would have contributed to the reported issue.The device passed all functional testing.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#: 1627487-2015-05090.On (b)(6) 2015, the patient underwent a permanent implant procedure.During the procedure, a significant amount of scar tissue was present.On the evening following the procedure, the patient began to experience lower extremity weakness, loss of movement in her right leg, and numbness below her waist.That same evening the doctor relocated the patient's lead but resolution was not obtained.The following day, the patient went back into surgery.During the procedure, the doctor explanted and replaced the patient's lead (with a different model).Surgical intervention yet again did not provide resolution.In turn, the doctor had the patient stay in the hospital in an effort to provide resolution.Unfortunately, the symptoms never resolved while the patient was hospitalized.Over time the patient also began to experience urinary incontinence and decreased bowel movement.On (b)(6) 2015, the patient underwent further surgical intervention.During the procedure, the lead was found to have migrated.The doctor repositioned the lead several times along with multiple programming attempts but only stimulation in unintended areas was achieved.In turn, the doctor explanted the patient's scs system.Post-op, the patient was prescribed acute physical therapy via a rehabilitation facility.Post-op, the patient also regained movement of both legs.

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.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• 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: 4555918
• MDR Text Key: 5770357
• Report Number: 1627487-2015-05089
• 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: 04/08/2015

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: 04/28/2016
• Device Model Number: 3286
• Device Lot Number: 4581909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 03/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• 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
• Treatment: MODEL: 3789, SCS IPG
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR