MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; Stimulator, spinal-cord, implanted (pain relief)

Model Number 1192

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

Patient Problem Sepsis (2067)

Event Date 10/25/2023

Event Type  Injury  

Event Description

It was reported the patient was admitted to the hospital due to an infection on (b)(6) 2023.The patient was declared septic and intubated.The system was explanted on (b)(6) 2023.Wherein it was found the infection had spread.The patient passed away on (b)(6) 2023.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: Stimulator, spinal-cord, implanted (pain relief)
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18743773
• MDR Text Key: 335811759
• Report Number: 1627487-2024-07085
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1192
• Device Lot Number: 9110826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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
• Patient Outcome(s): Hospitalization; Other; Death
• Patient Sex: Female