MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

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

Patient Problems Skin Erosion (2075); Post Operative Wound Infection (2446)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

"the reported event of infection cannot be analyzed via laboratory testing" regardless of whether device has returned.This will preclude the need for doing supplement for product return.(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.

Event Description

Device 3 of 4.Reference mfr report: 1627487-2016-04725.Reference mfr report: 1627487-2016-04726.Reference mfr report: 1627487-2016-04728.It was reported the patient's lead had eroded through the midline incision due to infection.The patient's entire scs system was removed and the wound washed out.The patient was treated with antibiotics.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• 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: 5947573
• MDR Text Key: 54626129
• Report Number: 1627487-2016-04727
• 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: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 1192
• Device Lot Number: 5305010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2015
• 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
• Treatment: MODEL 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 50 YR