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

Model Number 3228

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tingling (2171); Inadequate Pain Relief (2388); Numbness (2415)

Event Date 01/21/2014

Event Type  Injury  

Event Description

Information provided from the medical chart review indicates the patient experiences ineffective stimulation, numbness, tingling and weakness despite multiple reprogramming.Additional information is needed to clarify the nature of the patient's issues.Sjm was made aware of the issues on 12/10/2014, and the patient's scs system was not evaluated by an sjm representative to verify and/or troubleshoot the reported issue.

Event Description

Additional information provided, indicated the patient's scs system was explanted.

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.

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
• MDR Report Key: 4371929
• MDR Text Key: 5114220
• Report Number: 1627487-2014-03800
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2015

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: 07/28/2013
• Device Model Number: 3228
• Device Lot Number: 3439212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/10/2015; 04/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2011
• 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 3788, SCS IPG; MODEL 1194(2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 50 YR