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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot#: (b)(4), ubd: 08-nov-2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 08-nov-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported via the manufacturer representative that the patient had been getting good pain relief since implant.The patient then bent and twisted and lifted and the pain returned.The patient switched to group b and was going to meet with the representative to diagnose the issue.It was unknown if the issue was resolved at the time of the report.Additional information was received via a manufacturer representative from a consumer regarding the patient on 2020-jun-08.It was reported by patient that patient lost therapy 3 days after the implant.X-ray confirmed the lead moved.Patient was told that she can do household activities such as washing dishes by rep, but other reps told her she should have been on bed rest.Patient has been in excruciating pain for a week, when stimulation is on her pain level goes from a 7 to a 20.The pain goes down from her leg, up to her neck and shoulder.Patient feels like she's on fire and she can't extend her arms and legs, that she can't move.Patient said a rep won't let her see the doctor and the doctor won't see the patient without the rep.Later, the rep reported that patient is reporting extreme pain and inability to strain when using restroom or stand up.Stimulation is off at this time.Additional information was received from a manufacturer representative regarding the patient on 2020-jun-12.It was reported that the manufacturer representative met with the patient, and the cause of the lead migration was determined to be that the patient was bending and lifting after surgery.The patient was reprogrammed which resolved the issues.There were no further complications reported or anticipated.

• 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: 10175511
• MDR Text Key: 195842853
• Report Number: 3004209178-2020-10691
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 06/19/2020
• Date Device Manufactured: 02/10/2020
• 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 Age: 26 YR