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

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint of infection cannot be confirmed 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

Device 2 of 3.Reference mfr.Report: 1627487-2016-02313, reference mfr.Report: 1627487-2016-02312.The patient received two scs anchors from the same lot (device 3).It was reported the patient experienced a blister-like spot at the midline lead incision.The patient was given antibiotics as treatment.Due to drainage at the blister site, the patient was sent to a wound specialist for further inspection.Per the wound specialist and pain physician, there appeared to be 'something superficial' at the wound site which was suspected to the anchor.Surgical intervention was undertaken on (b)(6) 2016 wherein the leads and anchors were reburied and the wound /incision sites were cleaned.However, the wound site continued to exhibit drainage.An additional surgery is planned as the next course of action to address the issue.

Event Description

Device 2 of 3: reference mfr.Report: 1627487-2016-02313; reference mfr.Report: 1627487-2016-02312.Follow-up identified the patient underwent surgery to explant the entire system on (b)(6) 2016.The patient's wound site is reportedly healing well.

• 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: 5644041
• MDR Text Key: 44837881
• Report Number: 1627487-2016-02314
• 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: 06/01/2016

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: 01/31/2017
• Device Model Number: 3186
• Device Lot Number: 4986224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2015
• 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