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 Problem Unspecified Infection (1930)

Event Date 09/02/2021

Event Type  Injury  

Event Description

It was reported the patient the patient has an infection.As a result, surgical intervention may be pending to explant the system.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg and lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.Antibiotics were administered to the patient to address the issue.As a result, a device history record was performed to review and confirm the sterility of the ipg and lead(s).Based on the documents reviewed, the source of the infection remains unknown.

Event Description

Related manufacturer reference number: 1627487-2021-17182.It was reported the infection was at both the ipg and lead site.Surgical intervention was undertaken to explant the entire system.The infection was treated via antibiotics.

• 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: 12490690
• MDR Text Key: 272118622
• Report Number: 3006705815-2021-04634
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

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: 09/03/2021
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000085830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/22/2021; 09/23/2021
• Supplement Dates FDA Received: 09/22/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS PADDLE LEAD
• Patient Outcome(s): Other