MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number 3219

Device Problem Difficult to Advance (2920)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 02/18/2015

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report#1627487-2015-08148.

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#1627487-2015-08148.It was reported during a revision procedure, neuromonitoring revealed a deficiency in the patient's right foot after the ipg replacement.Reportedly, the physician encountered difficulty with lead placement due to scar tissue.Although the issue resolved with the connection of the new lead to the new ipg, the physician elected not to implant the patient.As a result, the case was abandoned.

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 TRIPOLE 16 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: 4615181
• MDR Text Key: 5720878
• Report Number: 1627487-2015-08147
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

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: 01/28/2017
• Device Model Number: 3219
• Device Lot Number: 4945336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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: 39 YR