MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD

Model Number 3228

Device Problems Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/01/2018

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.During processing of this complaint, attempts were made to obtain explant date.Further information was requested but not received.

Event Description

Related manufacturer reference number 1627487-2020-03801.It was reported that ipg had migrated and was protruding, which ruptured the skin on the implant site.Patient also experienced bleeding from the implant site.As a result, patient underwent surgical intervention wherein the ipg was explanted on unknown date.During the explant procedure, the patient's lead was partially cut off, and the rest of the lead remained implanted.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS PADDLE LEAD
• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9960945
• MDR Text Key: 187676604
• Report Number: 1627487-2020-03802
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401913
• UDI-Public: 05414734401913
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2020

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: 06/28/2013
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 3416657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2011
• 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 IPG
• Patient Outcome(s): Other
• Patient Weight: 79