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 Pain (1994); Fluid Discharge (2686); Implant Pain (4561)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced pain at the ipg site.As a result, surgery occurred in which the ipg site was opened, and fluid drained out, which resolved the issue.Pressure dressings were used as well.Device information is not yet known.

Manufacturer Narrative

A patient experienced pain at the ipg site was reported to abbott.As a result, surgery occurred in which the ipg site was opened, and fluid drained out, which resolved the issue.Pressure dressings were used as well.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

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.

Event Description

Additional information received indicated the issue did not resolve following the procedure on (b)(6) 2020 and the patient underwent additional intervention on (b)(6) 2021 wherein the ipg was repositioned to further address the issue.Reportedly, the pain at the ipg site issue resolved.

• 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: 10841012
• MDR Text Key: 216313106
• Report Number: 3006705815-2020-32550
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

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: 03/05/2022
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 7403382
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/14/2020
• Supplement Dates Manufacturer Received: 12/21/2020; 01/05/2021
• Supplement Dates FDA Received: 12/21/2020; 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 73