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); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id :977a260, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 11-dec-2024, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 19-nov-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).Patient reported to hcp that the stimulator was not helping and getting sensations in the side.X-ray had confirmed that both leads had migrated down two levels. patient said he didn't fall and doesn't recall any event that moved the leads.Hcp states that he isn't careful and might be trying to avoid a jail sentence. x-ray was performed about a week before the lead revision. leads were replaced because manufacturer doesn't make revision kits anymore and stylets and needles were needed, so the new leads were used. leads were replaced, old ones discarded.System is implanted and in use.Patient went home after surgery.The issue 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: 11562369
• MDR Text Key: 242275773
• Report Number: 3004209178-2021-04825
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2021
• Date Device Manufactured: 01/22/2021
• 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: 66 YR