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); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturer representative reported that the patient had a return of chronic pain in early (b)(6) 2020.There were no falls reported but the patient stated that if felt like something moved one morning in early (b)(6).It was noted that there was an abscess at the pocket incision and a bulge near the lead/anchor and that the bulge had been present since implant and would get bigger and smaller.No programming or x-rays were taken due to the abscess and a surgeon was requested to assess the pocket site.The patient was instructed to turn off the stimulation and not turn it back on until there was a plan for wound care and an x-ray.The issue was not resolved at the time of the report.No device issues reported.Additional information received from the manufacturer representative reported that when the patient stated it felt like something moved one morning that coincided with a change in the stimulation therapy.It was unable to be determined if the abscess was related to an infection, but it was noted that the patient had an increased risk for infection and delayed wound healing given her diabetes.The cause of the event was not determined.The patient had a pocket revision completed on (b)(6).The stimulator was relocated to the opposite side and the surgeon noted no signs of pocket infection.The bulge near the anchor site was assessed by the surgeon and a compression device applied after closure of the spinal incision.The pocket issue was resolved.

• 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: 10103101
• MDR Text Key: 193944013
• Report Number: 3004209178-2020-09406
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Date Device Manufactured: 06/11/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 48