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

Model Number 3660

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient is experiencing a overstimulation at the ipg site beginning on an unknown date.As result, the ipg was explanted on (b)(6) 2020.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively 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: 10886514
• MDR Text Key: 217923450
• Report Number: 3006705815-2020-32827
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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: 12/30/2020

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: 04/15/2021
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000078960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other