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

Model Number 3664

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.

Event Description

It was reported the patient experienced uncomfortable stimulation from the ipg site.In turn, surgical intervention may be pending.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.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.

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.

Event Description

Related manufacturer reference number: 1627487-2021-01980 , 1627487-2021-01981.Additional information indicates the system was explanted and replaced to address the issue.

• 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: 10899595
• MDR Text Key: 218198107
• Report Number: 1627487-2020-48188
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2019
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 6011913
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/18/2020; 02/19/2021
• Supplement Dates FDA Received: 12/21/2020; 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG SLIM TIP LEAD X2
• Patient Outcome(s): Other
• Patient Weight: 104