MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient alleges pocket heating on several occasions since being implanted in 2016.The ipg was explanted in (b)(6) 2019 due to end of life.(see mfr number 1627487-2019-08010).

Manufacturer Narrative

The reported event, of pocket heating was not confirmed.The alleged complaint for pocket heating could not be tested, due to insufficient battery voltage.Since cutting the can open to supply, sufficient battery voltage would invalidate the pocket heating test.Destructive analysis was not performed on the device.Testing of the ipg did not identify any anomalies, that would contribute to the alleged complaint of pocket heating.The ipg performed normally, during testing.And a review of the ipg logs indicated, normal current draw over the life of the ipg.The intense heating and burning allegation, that the patient experienced in late (b)(6) of 2019, postdates the ipg end of service (eos).Ipg stimulation turned off, due to eos on (b)(6) 2019.Since ipg stimulation was turned off, due to eos.The alleged complaint of pocket heating could not have been caused by the ipg.

• Brand Name: PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9682592
• MDR Text Key: 178181633
• Report Number: 1627487-2020-01387
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2018
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 5500228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR