MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM DRG IMPLANTABLE PULSE GENERATOR; DRG IPG

Model Number 3664

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient experienced pain at ipg pocket site.Reportedly, patient lost 30 pounds and the ipg migrated in the pocket.As a result, surgical intervention was undertaken on (b)(6) 2020, wherein the ipg was placed deeper within the same pocket.Additional follow-up information received identified that surgical intervention was undertaken on (b)(6) 2020 wherein the entire system was explanted to address the issue.

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.

• Brand Name: PROCLAIM DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: DRG IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10518392
• MDR Text Key: 206485506
• Report Number: 1627487-2020-31215
• 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
• Report Date: 11/24/2020

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: 01/02/2021
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 6788125
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 88