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

Model Number 3664

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

Patient Problem Implant Pain (4561)

Event Date 02/07/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 1627487-2023-05557, 1627487-2023-05562, 1627487-2023-05604 it was reported that the patient had a fall and was experiencing pain at the site of their drg ipg.It was also noted that the patient will need to undergo an mri and has been unable to enable mri mode due to impedances on multiple contacts of one of their drg leads.The patient's second lead was unable to be activated due to the lead aggravating the patient's pain.Surgical intervention was undertaken on (b)(6) 2023 wherein the patient's drg system was explanted except a fragment of the s1 lead which could not be removed.

Manufacturer Narrative

Section b3: event date is estimated.

Manufacturer Narrative

The patient underwent a system explant due to unbearable pocket pain.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: DRG PULSE GENERATOR
• 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: 18196176
• MDR Text Key: 328888091
• Report Number: 1627487-2023-05556
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: 3664
• Device Lot Number: 6846124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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): Other
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 86 KG