MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problem Device Remains Activated (1525)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient experienced undesired stimulation regardless if therapy was on or off following an mri procedure.As a result, surgical intervention was undertaken wherein the ipg was explanted to address the issue.

Event Description

Related manufacturer reference number: 1627487-2020-33051, 1627487-2020-33052.Additional information received indicated the patient underwent surgical intervention on (b)(6) 2020 wherein the leads were explanted to further address the issue.

Manufacturer Narrative

The reported uncomfortable stimulation was not confirmed.This issue cannot be fully analyzed with product testing.The ipg was returned without any visible anomalies or damage that would contribute to the reported issue.It was responsive and communicated with lab utilities.It was running the therapy app and functional.It successfully bonded with a lab cp without any connectivity issues.Programming the ipg and observing the outputs did not display any anomalous outputs when monitored on an oscilloscope.The magnet feature functioned as intended.The ipg was tested to manufacturing specifications using the auto tester and passed all tests.The returned ipg functioned as intended.The cause of the reported event could not be conclusively determined.

• Brand Name: PROCLAIM 7 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: 10558246
• MDR Text Key: 207694208
• Report Number: 3006705815-2020-31493
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• 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,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: A000082641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD X2
• Patient Outcome(s): Other
• Patient Weight: 86