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 Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient experienced wound dehiscence at the ipg site incision and fluid was leaking.The patient went to the emergency room where an infection was identified.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the entire system was explanted.

Event Description

Additional information indicates the patient was hospitalized overnight and received both oral and iv antibiotics.The infection has since been resolved.

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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 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: 12143086
• MDR Text Key: 260717061
• Report Number: 3006705815-2021-03331
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000108016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 45 YR
• Patient Weight: 88