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

Model Number 1192

Device Problem Device Damaged by Another Device (2915)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 4 of 4.Reference mfr.Report#: 1627487-2017-01791, reference mfr.Report#: 1627487-2017-01792, reference mfr.Report#: 1627487-2018-00315.Follow-up revealed the high impedance was related to lead fractures located at the anchor sites.As a result, the patient's leads and anchors were explanted and replaced.

Event Description

Device 4 of 4, reference mfr.Report#: 1627487-2017-01791.Reference mfr.Report#: 1627487-2017-01792.Reference mfr.Report#: 1627487-2018-00315.Follow-up revealed surgical intervention resolved the patient's issue.

• 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: 7173183
• MDR Text Key: 96665625
• Report Number: 1627487-2018-00316
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2018
• Device Model Number: 1192
• Device Lot Number: 5591920
• Other Device ID Number: 05414734400671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• 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: 3662, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 45 YR