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); Energy Output Problem (1431); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial #: unknown, implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.Information was reported that the patient returned to the office for reprogramming because the lead migrated down.The rep was doing reprogramming with high density settings, but needs to increase the recharge interval.It was reviewed that lowering the settings and the number of electrodes will increase the recharge interval and also cycling will increase recharge interval.The rep reprogrammed the patient's settings.The patient had an increase in pain and this was considered sudden.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep) reporting that the rep was uncertain when the patient first noticed the change in their therapy/lead migration.They clarified that both percutaneous leads moved down one half a vertebral body.They stated they still covered the targeted 9/10 inner space.The rep stated they were not sure the cause of the lead migration.Reprogramming was done to resolve the lead migration and increased pain.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

Manufacturer Narrative

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7629605
• MDR Text Key: 112137116
• Report Number: 3004209178-2018-14111
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

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: 02/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/10/2018; 08/08/2018
• Supplement Dates FDA Received: 07/16/2018; 10/05/2018
• Date Device Manufactured: 02/24/2018
• 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