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 Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 02/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported an infection.No factors that may have led or contributed to the issue were reported and no actions were taken to resolve the issue.The issue was not resolved and no surgical intervention occurred but was unknown if surgical intervention was planned.Relevant medical history includes neuropathic pain.Additional information received reported that the cause of infection was not determined although it was confirmed to be staph aureus.Actions taken included the system (lead plus implantable neurostimulator) was explanted and antibiotics was administered.The outcome of the issue reported that the patient was stable and under observation.

Manufacturer Narrative

Product id neu_unknown_lead, serial# unknown.Product type lead.Correction: upon further review, a lead that was part of this system was also involved in this event and was included.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 lead model, serial number, and implant date were unknown and would not be made available.The explant date was also unknown and would not be made available.It was noted that the lead was discarded by the customer.

Manufacturer Narrative

Product id: neu_unknown_lead, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9805300
• MDR Text Key: 182537958
• Report Number: 3004209178-2020-04909
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

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: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/11/2020; 05/28/2020
• Supplement Dates FDA Received: 03/25/2020; 06/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2019
• 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): Required Intervention