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

Model Number 97702

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

Patient Problems Purulent Discharge (1812); Inflammation (1932); Nausea (1970); Swelling (2091); Vomiting (2144); Chills (2191); Sweating (2444); Pallor (2468)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that the patient had experienced inflammation and a ¿possible implantable neurostimulator (ins) infection¿ at the ins site/sutures.The patient was admitted to the hospital and was receiving intravenous antibiotics at the time of report; the issue remained unresolved at that time.A physician who was involved with the patient¿s care reported on 2020-feb-03 that he ¿didn¿t think there was any infection, only inflammation.¿ the results of a culture attempt remained unknown as of (b)(6) 2020.There were no surgical interventions performed and it was asked, but unknown whether any were planned.A number of external factors were reported that may have led or contributed to the issue: the procedure took a long time, the patient had many comorbidities, and the patient did not attend follow-up appointments for wound checks/suture removal despite multiple options being offered.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the hcp reported the patient ¿had marked symptoms of infection by the time she came to the clinic.¿ it was noted the patient had ¿nausea and vomiting, rigors, pale and clammy¿ and ¿there was notable swelling and purulent discharge from the suture site.¿ the patient was commenced on oral antibiotics by her general practitioner prior to being swabbed for infection, which the hcp ¿believed was why she had a negative swab.¿ it was noted the patient was admitted to the hospital and commenced on intravenous antibiotics upon reporting with her ¿possible infection.¿ the patient had since been discharged from the hospital and was ¿sounding much better again¿ according to the hcp.It was noted the patient had a long-term prescription for antibiotics and that the hcp had stressed the significance of taking the entire course.It ¿sounded as though she (the patient) was back on track¿ at the time of follow-up.The hcp noted that she had made several attempts to see the patient for suture removal leading into the new year and again in early(b)(6) 2020, but the patient ¿unfortunately did not attend or follow the advice she was given.¿ the patient¿s ins was put in an antibiotic pouch at the time of implant, which the hcp stated was ¿what really saved her.¿ no further complications were reported or anticipated.

• 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: 9671522
• MDR Text Key: 178355077
• Report Number: 3004209178-2020-02617
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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: 12/28/2020
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/26/2020
• Date Device Manufactured: 06/28/2019
• 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; Required Intervention