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

Model Number 3186

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 04/07/2015

Event Type  Injury  

Event Description

Follow-up revealed surgical intervention was undertaken on (b)(4) 2015 during which time the two leads were explanted and replaced with new models.The issue is resolved.

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

The patient received two leads with the same lot number.It was reported during reprogramming the patient experienced uncomfortable stimulation in her stomach when the amplitude was increased.Troubleshooting was unable to resolve the issue.Reportedly, x-rays were taken and results are normal.However, the physician suspects lead damage from a previous ipg revision (reference mfr report#1627487-2015-01130).Surgical intervention may be undertaken as the next course of action.

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: OCTRODE 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: 4789343
• MDR Text Key: 5847106
• Report Number: 1627487-2015-08289
• 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: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 3186
• Device Lot Number: 3546973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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 3789, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 45 YR