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

Model Number 97715

Device Problems Energy Output Problem (1431); Material Deformation (2976); Insufficient Information (3190)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 01/10/2022

Event Type  Injury  

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that patient's device was ¿acting up¿ and ¿will only read me as in prone position no matter what position i am in.¿ she said she did have an episode of overstimulation while upright related to this.Patient has turned off adaptive stim. patient is in florida currently.Her managing doc and rep are in michigan.So cannot trouble shoot until she returns.Has appt with hcp on (b)(6) rep reported battery is suspected of flipping in pocket.Also 8-15 lead was completely coiled inside of pocket of ins; x-ray confirmed.Turned off adaptive stim and put her on dtm for the one remaining lead.Rep reported issue not resolved; was going to have revision but pt had a fib.Rescheduling.

Manufacturer Narrative

Concomitant medical products: product id: 977a260 serial# (b)(4), product type: lead.Product id: 977a260, serial# (b)(4), product type: lead.Other relevant device(s) are: ubd: 22-mar-2025, udi#: (b)(4); ubd: 19-may-2025, udi#: (b)(4).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
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14211827
• MDR Text Key: 290112713
• Report Number: 3004209178-2022-05261
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2022
• Date Device Manufactured: 05/20/2021
• 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: 74 YR
• Patient Sex: Female