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

Model Number 3660

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

Patient Problems Pain (1994); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

It was reported that the patient experienced pain at the ipg site due to a seroma.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced and the ipg pocket site was repositioned.Stimulation was restored following the procedure and the ipg site pain has resolved.

• Brand Name: PROCLAIM 5 ELITE
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8562659
• MDR Text Key: 143478429
• Report Number: 3006705815-2019-01445
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2020
• Device Model Number: 3660
• Device Lot Number: A000057650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 53