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

Model Number 3660

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/15/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

Event Description

It was reported the patient underwent a lead revision on (b)(6) 2019 (related manufacturer reference number: 3006705815-2019-01413) where the device was not placed in surgery mode.Subsequently, the rep was unable to successfully connect to the ipg and the clinician programmer displayed an error message.Troubleshooting was attempted by the company representatives to no avail.Surgical intervention was undertaken on (b)(6) 2019 where the ipg was explanted and replaced.Issue resolved.

• Brand Name: PROCLAIM 5 ELITE
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8760761
• MDR Text Key: 150022719
• Report Number: 3006705815-2019-02544
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: 3660
• Device Lot Number: A000068125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 77