MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 90 CM; PERCUTANEOUS LEAD

Model Number	3159
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-24132, related manufacturer reference number: 1627487-2020-24133, related manufacturer reference number: 1627487-2020-24135, related manufacturer reference number: 1627487-2020-24136.It was reported that patient is experiencing ineffective stimulation.Patient may undergo surgery to correct this issue.Patient is stable.
Event or Problem Description
It was reported that patient underwent surgery on (b)(6) 2020, wherein their implantable pulse generator was replaced.Leads were previously reported on but are no longer reportable as ipg was responsible for ineffective stimulation.Patient is stable.

• Brand Name: QUATTRODE LEAD, 3/6MM, 90 CM
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10417396
• Report Number: 1627487-2020-24134
• Device Sequence Number: 2682832
• Product Code: LGW
• UDI-Device Identifier: 05414734401630
• UDI-Public: 05414734401630
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 3159
• Device Catalogue Number: 3159
• Device Lot Number: 3880580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EON MINI IPG, 16-CHANNEL RECHARGEABLE; EXTENSION, DUAL 4 CHANNEL 10CM; EXTENSION, DUAL 4 CHANNEL 10CM; QUATTRODE LEAD, 3/6MM, 90 CM
• Outcome Attributed to Adverse Event: Other