MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient experienced a burning sensation at the ipg pocket site.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.Post-operatively, the issue resolved and stimulation therapy was restored.

Manufacturer Narrative

The reported wound issue and pocket heating were not confirmed.The wound issue could not be confirmed with product testing.As received, normal pairing and bluetooth (ble) communication was observed.The uep inductive tool showed it was running the therapy application which is a normal indication.To address the pocket heating issue, the field scenario was recreated by attaching the ipg to a load block, placing in a heated chamber and turning on stimulation.After 3 hours, the temperature of the ipg increased by 0.4°c degrees.As the rise in temperature was less than 2 degrees, it met the product specification for heat generation during use.The ipg was tested to manufacturing specifications using the auto tester and passed all tests.No physical or functional anomaly was identified during analysis that would contribute to the reported issue was observed.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 12194338
• MDR Text Key: 262408355
• Report Number: 3006705815-2021-03538
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• 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
• Report Date: 10/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000093870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 112