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

Model Number NMD0005

Device Problem Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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.

Event Description

It was reported the patient's ipg was inoperable.Surgical intervention took place wherein the ipg was explanted and replaced to resolve the issue.

Manufacturer Narrative

D1 - brand name.D4 - model number.

• Brand Name: SCS CONVENTIONAL IPG
• 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: 12485031
• MDR Text Key: 271870637
• Report Number: 3006705815-2021-04619
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: NMD0005
• Device Catalogue Number: 3660
• Device Lot Number: A000113027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91