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 Erosion (1750); Inflammation (1932); Post Operative Wound Infection (2446)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The returned product was not analyzed as the complaint of infection could not 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 1 of 4.Reference mfr.Report: 1627487-2015-21270, reference mfr.Report: 1627487-2015-21271, reference mfr.Report: 1627487-2015-21272.The patient received an occipital (off-label) system.It was reported the patient experienced inflammation near the left-occipital lead site.Upon evaluation, the physician determined the left occipital lead had eroded through the patient's skin.Due to suspected infection, the patient was given antibiotic cream.Subsequently, the patient's entire system was explanted.Follow-up identified the patient's infection has healed.

• 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: 5211789
• MDR Text Key: 30802104
• Report Number: 1627487-2015-21269
• 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
• Report Date: 10/19/2015

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: 06/28/2016
• Device Model Number: 3186
• Device Lot Number: 4636579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 49 YR