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 Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-00910 , 1627487-2021-00911.It was reported the patient experienced an allergic response.There is a raised rash across the neck and head.A patient contact material kit was ordered for allergy testing which confirmed the patient is allergic to stainless steel and nickel.The ipg and leads both have materials that could come into contact with the patient during surgery and once implanted.Surgical intervention may be pending.

Event Description

Additional information indicates the port plugs were explanted and replaced with modified extension leads on (b)(6) 2021 to address the issue.

Event Description

Additional information indicates the system was explanted.

Manufacturer Narrative

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 incident could not 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
• MDR Report Key: 11279311
• MDR Text Key: 230276158
• Report Number: 1627487-2021-00909
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 7499623
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG SLIM TIP LEAD X2; DRG SLIM TIP LEAD X2
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 100