MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR; DRG IPG

Model Number 3664

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/20/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 1627487-2023-04808.It was reported that there was a suspected infection at the ipg site and the patient's s2 lead migrated which was verified through x-rays.On (b)(6) 2023 the patient underwent surgery to explant and replace the lead back at the correct location and the physician did not believe the ipg site was infected upon exploring the ipg pocket site.Effective therapy was established postoperatively.

Manufacturer Narrative

Date of event is estimated.Attempts were made to obtain complete patient information.Further information was requested but not received.

Manufacturer Narrative

A device history record was performed to review and confirm the sterility of the ipg.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: DRG IPG
• 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: 17895221
• MDR Text Key: 325239860
• Report Number: 1627487-2023-04807
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• 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
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3664
• Device Lot Number: T00005527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Treatment: SCS LEAD.
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female