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 Implant Pain (4561)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.The allegation is against [1] of [2] [lead]; however, it is unknown which [lead(s)], therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9061760.

Event Description

Related manufacturer reference number: 1627487-2024-07516.It was reported that the patient was developing complex regional pain syndrome at the ipg site.It was also reported that the patient was not getting sufficient pain relief.Surgical intervention may take place at a future date to address the issue.Investigation was unable to determine which of the leads attributed to the event.

Event Description

Additional information was received stating that surgical intervention took place where the system was explanted to address the issue.

Manufacturer Narrative

Date of event estimated.

Manufacturer Narrative

Date of event estimated.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 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: 18913211
• MDR Text Key: 337770616
• Report Number: 1627487-2024-07517
• 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,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: T00005476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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: DRG LEAD
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 75 KG