MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3086

Device Problems Cut In Material (2454); Impedance Problem (2950)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Post Operative Wound Infection (2446)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product cannot be analyzed for the complaint of infection as the allegation cannot be confirmed or refuted via laboratory 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.(b)(4).

Event Description

It was reported the patient underwent a trial implant procedure on (b)(6) 2016.The patient stated she was experiencing pain at the lead insertion site since (b)(6) 2016.The patient was advised to call her physician or go to the emergency room, but the patient declined.An sjm representative met with the patient on (b)(6) 2016, for her scheduled trial lead pull.Upon inspection of the insertion site it was found to be uncovered, red, irritated and draining with no sign of tape or bandaging.The lead also appeared to be cut.The patient stated that a family member removed the tape and gauze because it was loose.It is unknown if scissors were used to cut the tape.The patient also reported an auto-reducing error message.The physician stated the incision site appeared to be infected with pus at the lead insertion site.The lead was removed and the site was washed out.The wound was covered, and the patient was started on oral and topical antibiotics.The patient was instructed to go to the er if there was no improvement.

Event Description

It was reported the patient's infection has resolved.

• Brand Name: OCTRODE
• 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: 5673312
• MDR Text Key: 45704407
• Report Number: 1627487-2016-02520
• 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: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3086
• Device Lot Number: 5347439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 67 YR