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

Model Number 3186

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

Patient Problem Bacterial Infection (1735)

Event Date 08/26/2014

Event Type  Injury  

Event Description

Device 2 of 3.Reference mfr report: 1627487-2014-02662, 02664.The pt received two leads from the lot number, and two anchors from the same lot number.It was reported the pt experienced an infection shortly after she was implanted with her scs system.The pt's daughter stated the pt was reportedly diagnosed with a staph infection, and the pt's entire scs system was removed.The pt's daughter stated the pt has reportedly recovered.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed found one non-conformance.The nonconforming units were replaced.The product met all final packaging/sterilization acceptance criteria prior to release for distribution.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 4117257
• MDR Text Key: 15175345
• Report Number: 1627487-2014-02663
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Model Number: 3186
• Device Lot Number: 3263518
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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: 73 YR