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

Model Number 3664

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient recently lost weight resulting in the implantable pulse generator (ipg) to move around in the ipg site.On (b)(6) 2020 surgical intervention took place wherein extensions were added and the ipg was relocated higher up the patient¿s backside.There were no complications during the procedure and therapy was resumed post procedure.Patient was stable.

Manufacturer Narrative

An ipg pocket revision was reported to abbott.The patient recently lost weight, causing the ipg to move in the pocket.The ipg site was located to a position higher up on the patient's back, and the issue was resolved.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 event 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: 10645602
• MDR Text Key: 210362376
• Report Number: 1627487-2020-32225
• 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
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 7013858
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 73