MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) IPG, 5.3AH, SCS, MEDTRONIC HEADER; SCS IPG

Model Number	3671
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported the patient is experiencing an infection at the ipg site.Patient was prescribed antibiotics.Surgical intervention may take place at a later date.
Event or Problem Description
Additional information received indicates the patient has a mrsa infection and has been prescribed clindamycin.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.
Event or Problem Description
Additional information received indicates the infection has resolved and the ipg was explanted and replaced.Date of explant is unknown.
Additional Manufacturer Narrative
Correction: d6b date of explant.Correction: h6 health effect clinical code.
Event or Problem Description
Additional information received indicates the ipg was not explanted and replaced a wound wash out was performed to resolve the issue.The ipg remains implanted and the infection has resolved.
Additional Manufacturer Narrative
Device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: IPG, 5.3AH, SCS, MEDTRONIC HEADER
• Common Device Name: 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19986710
• Report Number: 3006705815-2024-06179
• Device Sequence Number: 7060815
• Product Code: LGW
• UDI-Device Identifier: 05415067046390
• UDI-Public: (01)05415067046390(10)A000142846(17)250522
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/19/2024

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: 05/22/2025
• Device Model Number: 3671
• Device Catalogue Number: 3671
• Device Lot Number: A000142846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 09/13/2024; 10/23/2024; 11/18/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 08/27/2024; 10/07/2024; 11/15/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Female