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

Model Number 3660

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pain (1994); Swelling/ Edema (4577)

Event Date 01/11/2021

Event Type  Injury  

Event Description

It was reported the patient was experiencing pain and swelling at the ipg site.Patient also reported a fever with sweats.The physician stated the patient had cellulitis.As a result, the patient underwent surgical intervention during which the system was explanted with no complications.

Event Description

Related manufacturer report number: 3006705815-2021-00557, 3006705815-2021-00558, 1627487-2021-01174, 1627487-2021-01176.

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.Correction: section g2 - report source should have checked off health professional instead of user facility.This correction is reflected in this additional report 1.

• 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: 11256573
• MDR Text Key: 229577921
• Report Number: 3006705815-2021-00350
• 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: 02/10/2021

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: 05/27/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000097667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/31/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD (X2).; SCS LEAD ANCHOR (X2).
• Patient Outcome(s): Other
• Patient Weight: 73