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

Model Number 3664

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

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Section b3: date of event is estimated.Section d4: lot number is unknown.Section d4: expiration date is unknown.Section h4: device manufacture date is unknown.

Event Description

It was reported that the ipg had eroded through the skin and was exposed and changed to the abdomen.The patient did not report accidents, falls, or trauma.Patient was admitted to the emergency room as the incision site turned red and the area was hot.Surgical intervention was undertaken and when the incision site was opened, there was discharge, and the physician explanted the entire system.Patient was given antibiotics.

Manufacturer Narrative

A patient's ipg eroded through the skin was reported to abbott.It was determined the ipg was exposed and changed to the abdomen.The patient was admitted to the emergency room as the incision site turned red and the area was hot.Surgical intervention was undertaken and when the incision site was opened, there was discharge, and the physician explanted the entire system.The patient was given antibiotics.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2023-04956.

• Brand Name: PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS 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: 17946618
• MDR Text Key: 325794614
• Report Number: 1627487-2023-04932
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• 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: DRG LEAD (2).
• Patient Outcome(s): Other; Hospitalization