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); Energy Output Problem (1431); Low impedance (2285); Charging Problem (2892)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2021

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.Product id: 977a260, serial/lot #: (b)(4), ubd: 02-aug-2023, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 26-jul-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.Caller told by pt that they are charging more often.Pt does have a short circuit on 2/10 but pt was not programmed on these together coming into session today.A revision of entire system is being planned with dr.(b)(6) doing revision.Pt had a fall about a month ago and another fall about 2 weeks ago and since then pt's stimulation has felt different.While checking impedances today, #8 shows as an open circuit and 2-10 are a short at 180 ohms.Coming into the session today, pt was programmed with 8 and 2.Caller was able to reprogram pt today and get stim on pt's left side from pt's back to pt's feet (target areas) but on right side, the stimulation wouldn't go past pt's right thigh.Xray shows that lead has migrated from bottom of t7 to top of t9.They are planning a revision and planning to replace all components.

• 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: 11380835
• MDR Text Key: 234976467
• Report Number: 3004209178-2021-03269
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Date Device Manufactured: 09/09/2019
• 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: 79 YR