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 Hypersensitivity/Allergic reaction (1907)

Event Date 10/30/2022

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.

Event Description

Related manufacturer report number: 3006705815-2022-18115.It was reported that the patient was experiencing hypersensitivity to their drg and scs ipgs.Surgical intervention was undertaken and both systems were explanted.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15815735
• MDR Text Key: 303829961
• Report Number: 1627487-2022-06265
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 7311878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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
• Treatment: DRG LEAD (X2).
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 88 KG