MAUDE Adverse Event Report: ABBOTT MEDICAL; SCS ANCHOR

Model Number ANCHOR

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

Patient Problem Unspecified Infection (1930)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Reporter phone number (b)(6).Date of event is estimated.During processing of this complaint, attempts were made to obtain complete device information.The unique device identifier (udi #) is unknown because the lot and part number were not provided.

Event Description

Related manufacturer reference numbers: 3006705815-2021-04222, 1627487-2021-16593.It was reported the patient experienced an infection at the back and ipg site.Patient has placed on iv antibiotics and vac therapy.Surgical intervention took place wherein the system was explanted.Infection has resolved.

Manufacturer Narrative

Based on the documents reviewed, the source of the infection remains unknown.

• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12374496
• MDR Text Key: 268368730
• Report Number: 1627487-2021-16594
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ANCHOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 3186 LEAD; SCS IPG
• Patient Outcome(s): Other
• Patient Age: 62 YR