MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG, 16CH, RECHARGEABLE; SCS IPG

Model Number 3772

Device Problem Difficult to Remove (1528)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain complete device, and event information.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

Related manufacturer reference number: 1627487-2021-17074.It was reported that the patient's system had high impedances on contacts 1, 3, and 5.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the extension and ipg were explanted and replaced.During the procedure, it was noted that the extension was broken in the ipg header between electrode 1 and 2.

Manufacturer Narrative

The reported event of high impedance was not confirmed.The returned ipg passed all functional testing (bench and autotest).No root cause was identified for the reported issue.

• Brand Name: PRODIGY MRI IPG, 16CH, RECHARGEABLE
• 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: 12491034
• MDR Text Key: 272016683
• Report Number: 3006705815-2021-04625
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: A000081704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION; SCS EXTENSION
• Patient Outcome(s): Other