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

Model Number 97715

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

Patient Problems Abscess (1690); Fever (1858); Foreign Body Reaction (1868); Unspecified Infection (1930); Skin Discoloration (2074); Swelling (2091); Discharge (2225); Complaint, Ill-Defined (2331)

Event Date 10/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare provider via manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - spinal pain.It was reported that there was a possible infection at incision, midline incision and neurostimulator (ins) pocket site.It was reported the patient had a fever of 101 and swelling/redness at both incisions.Patient denied any drainage at the incision sites.Patient was given antibiotics on (b)(6) 2018.Hcp had labs drawn.Patient was seen on (b)(6), the hcp reported no swelling/redness/drainage at patient's midline site and minimal swelling.Hcp reported a little bit of redness at ins pocket incision site.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.It was reported that the patient was given a round of oral antibiotics on (b)(6).Rep met with the patient on (b)(6) and the incision was no longer red and patient had no fevers since before his hcp started on the antibiotics.Patient did still have some swelling which was relayed to the nurse.It is unknown if any further testing will be done.Per patient, symptoms have subsided since starting antibiotics on (b)(6) 2018.However, there is still swelling at the ins incision, but it does not cause pain.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.It was reported that the patient's system was explanted on friday, dec.14th due to the body rejecting device.Patient continued to have localize swelling at the spinal incision and then began having discharge from the spinal incision.Per the hcp, there was an inflammatory process going on, his tissue wouldn't even hold sutures.The hcp reported there were no signs of pus/ evidence of infection and body was just rejecting the device.Rep was made aware of this today 12/18.The device was not given back to return.The hcp stated he has been monitoring the patient's would cultures that have been unremarkable thus far and has the patient on antibiotics.

• Brand Name: INTELLIS
• 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: 8028038
• MDR Text Key: 125779071
• Report Number: 3004209178-2018-24434
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• Date Device Manufactured: 06/18/2018
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 76