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

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

Further device information was unable to be obtained.Date of event is estimated.The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

It was reported the patient's anchor remained implanted due to being left inside the patient when their scs system was removed for an mri.As a result, the anchor was later explanted.

Manufacturer Narrative

No product investigation could be performed as there were no complaint allegations present nor were the circumstances of the event attributed to the implanted system.

Manufacturer Narrative

Correction: section h10: unique device identifier (udi #): the udi is unknown because the lot number was not provided instead of blank.

• Brand Name: SCS 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10543992
• MDR Text Key: 207280372
• Report Number: 1627487-2020-31558
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 59 KG