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

Model Number 3789

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event and patient weight.Further information was requested but not received.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: 1627487-2021-18011, 1627487-2021-18012.It was reported that patient underwent surgical intervention on (b)(6) 2021 wherein the entire system was explanted for being nonfunctional.

Manufacturer Narrative

Correction: section e1: initial reporter-reporter name should have been banner (b)(6); reporter phone number should have been +1(623)327-5380; reporter address line 1 should have been (b)(6) reporter city should have been (b)(6); reporter state should have been selected (b)(6); reporter postal office or zip code should have been (b)(6).The reported event for ineffective stimulation/ipg inoperable was confirmed.The as-received ipg would not communicate due to a depleted battery.After the battery was recovered, the ipg communicated, charged, and passed functional testing to manufacturing specifications using the autotester.Unable to determine the cause of the reported event.

• Brand Name: PROTEGE IPG, 16-CHANNEL 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
• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12725460
• MDR Text Key: 279251853
• Report Number: 3006705815-2021-05374
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734405690
• UDI-Public: 05414734405690
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 3789
• Device Catalogue Number: 3789
• Device Lot Number: 4868724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/30/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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
• Treatment: SCS LEAD X2, MODEL: 3186
• Patient Outcome(s): Other
• Patient Sex: Male