MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE; SCS IPG

Model Number 3660

Device Problem Device Stops Intermittently (1599)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/31/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: the therapy date for the following device is unknown: model: 3189; scs lead, model: 3386, scs extension.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported (b)(6) the patient experienced intermittent stimulation.In addition, the patient stated experiencing increased pain due to the issue.Surgical intervention was undertaken to explant and replace the ipg in related reference mfr.Report: 1627487-2018-03052.Explant date is unknown at this time.

Event Description

Follow-up identified the patient's ipg was explanted on (b)(6) 2018.

Event Description

Follow-up identified the issue of intermittent stimulation has resolved with the new ipg.

• Brand Name: PROCLAIM 5 ELITE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7399098
• MDR Text Key: 104435702
• Report Number: 1627487-2018-03360
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2018
• Device Model Number: 3660
• Device Lot Number: 5474541
• Other Device ID Number: 05415067020192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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