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 09/26/2022

Event Type  Injury  

Event Description

It was reported that patient experienced an infection at the ipg site.Reportedly, patient had pain/throbbing at the ipg site and some fluid from the ipg site.Additionally, patient felt nauseous.In turn, patient was hospitalized with iv antibiotics to treat the infection.Later on, (b)(6) 2022 patient was feeling unwell with temperature.As such, surgical intervention took place on (b)(6) 2022 wherein the entire system was explanted to address the issue.Patient was admitted to the hospital for iv antibiotics.

Manufacturer Narrative

E1 reporter phone number: (b)(6).

Event Description

Additional information received indicates that the infection has resolved.

Manufacturer Narrative

The reported issue of ¿infection¿ cannot be confirmed through product analysis testing.The returned ipg successfully communicated with all lab utilities and passed all tests on the ate (automated test equipment).The returned ipg exhibited normal device characteristics during analysis.As a result, a device history record was performed to review and confirm the sterility of the ipg.Based on the documents reviewed, the source of the infection remains unknown.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15630031
• MDR Text Key: 301978507
• Report Number: 1627487-2022-05725
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: T00000622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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: DRG LEAD (X2)
• Patient Outcome(s): Other