MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Purulent Discharge (1812); Edema (1820); Discomfort (2330); Post Operative Wound Infection (2446)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional of a clinical study regarding a patient with an implantable neurostimulator (ins) for spinal pain and failed back surgery syndrome.It was reported that the wound was not closing and that were was possible infection concerns.The patient was advised to go to the emergency department.The wound was examined and it was gaping with purulent yellow discharge found.The patient was admitted to the hospital.The implanting physician examined the wound and determined there was a superficial skin infection with purulent discharge, minimal tenderness.The patient was afebrile.Laboratory testing specified a normal while blood cell count.The pocket was cleared with no infection and there were no systemic infection signs or symptoms (no fever, chills, fatigue, etc.).The doctor ordered cultures, started an iv of antibiotics, and consulted with infectious diseases for recommendations, including wound care consult.Medications were administered on (b)(6) 2017 an ultrasound on (b)(6) 2017 found small amount of edema, no fluid collection, and no abscess.The patient was discharged on 2b)(6) 2017 with improved wound appearance and no abscess per the ultrasound.The patient was discharged with course of po antibiotics course.On (b)(6) 2017, (b)(4) and dressing changes were performed to encourage wound healing.The event resolved without sequelae on (b)(6) 2017.The clinical diagnosis included a superficial wound infection and cellulitis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the event was unlikely related to the device or therapy and related to the implant procedure, and noted surgery/anesthesia.Seriousness was noted as required in-patient or prolonged hospitalization.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6979682
• MDR Text Key: 90325233
• Report Number: 3004209178-2017-22550
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Date Device Manufactured: 10/05/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR
• Patient Weight: 109