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); Unintended Collision (1429)

Patient Problems Fall (1848); Neurological Deficit/Dysfunction (1982); Dizziness (2194); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial# (b)(4), implanted: 2017-12-11, product type: lead.Product id: 977a275, serial#: (b)(4), implanted: 2017-12-11, product type: lead.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 14-jun-2021, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 14-jun-2021, udi#: (b)(4).(b)(4) pertain to product id: 977a275, serial# (b)(4), product type: lead and product id: 977a275, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient in a clinical study with an implantable neurostimulator (ins) for complex regional pain syndrome type i and spinal pain.It was reported on (b)(6) 2018, that the patient experienced problems with balance and feeling unsteady at high settings; reprogramming was done and an x-ray was ordered.On (b)(6) 2018, it was reported that the patient moving their neck resulted in falls and fine motor issues and the device was turned off until reprogramming could be done.The patient had dizziness that was felt to have been unrelated to the device, and they were losing control of their right hand when turning their head, felt clumsy, and fell on (b)(6) 2018.An x-ray showed the leads were at c3 and c4 and had moved from their initial placement of c2 and c3.Reprogramming was done on (b)(6) 2018 and (b)(6) 2018, with no relief.A physical exam on (b)(6) 2018, noted involuntary flexion of the right elbow with increased frequency settings, the patient had dizziness, and involuntary movements of the right-upper extremity (rue) when rotating, side-bending, or extending their neck.Reprogramming was done on (b)(6) 2018, with no relief.On (b)(6), it was reported that the patient was pregnant, and on (b)(6), it was noted that the therapy was turned off since discovering the pregnancy and there were no reports of dizziness or involuntary rue movement.It was noted that the event was related to the device or therapy and possibly related to the implant procedure.The outcome of the event was noted to have been unresolved with no further action planned.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 977a275, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id 977a275, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information was reported (the patient's weight was requested but it was reported to have been unmeasured).

• 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: 8104806
• MDR Text Key: 129168246
• Report Number: 3004209178-2018-26249
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Date Device Manufactured: 11/28/2017
• 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: 30 YR