MAUDE Adverse Event Report: ST JUDE MEDICAL, NEUROMODULATION EXCLAIM 8; SCS LEAD

Model Number 3225

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/29/2014

Event Type  Injury  

Event Description

Device 2 of 2.Refer to mfr report# 1627487-2014-20112.The patient has two scs lead.It is unk which one is related to the issue; therefore, both are being reported.It was reported during the ipg replacement procedure (refer to mfr report 1627487-2014-01393) that the physician determined fluid intrusion in the scs lead wire insulation.Diagnostics revealed invalid impedance values.The patient was able to received effective stimulation with reprogramming at time; however, the patient is no longer receiving stimulation due to auto-reduction.The patient is to consult with the physician regarding surgical intervention.

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 2 of 2.Reference mfr.Report# 1627487-2014-20112.

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: EXCLAIM 8
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION
• Manufacturer Contact: taruna sharma ; 6901 preston rd.; plano, TX 75024 ; 9725269635
• MDR Report Key: 4059348
• MDR Text Key: 4865917
• Report Number: 1627487-2014-20113
• 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: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: 3225
• Device Lot Number: 3936180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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: SCS IPG: MODEL 3788,; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 31 YR