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

Model Number 97715

Device Problems Break (1069); Electromagnetic Interference (1194); High impedance (1291)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37713, lot# serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2019, product type: implantable neurostimulator.Product id: 3888-45, lot#: v588266, implanted: (b)(6) 2011, product type: lead.Product id: 3888-45, lot#: v568713, implanted: (b)(6) 2011, product type: lead.Product id: 3777-75, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 3888-45, serial/lot #: (b)(4), ubd: 12-nov-2014, udi#: (b)(4).Product id: 3888-45, serial/lot #: (b)(4), ubd: 19-oct-2014, udi#: (b)(4).Product id: 3777-75, serial/lot #: (b)(4), ubd: 10-mar-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2019 the patient was admitted to the hospital with complaints of ongoing lumbar back pain around her spinal stimulation and abdominal pain as well as a burning pain radiating down her bilateral legs from the site of her stimulator.The patient was examined on (b)(6) 2019 by the healthcare provider (hcp) and requested a manufacturer's representative (rep) to discuss the spinal stimulator before making a decision.A rep evaluated the patient on (b)(6) 2019 and found the inss life span was to end in (b)(6) 2020.The rep also told the patient it was safe for her to undergo an mri even though the stimulator was not mri compatible.It was decided on (b)(6) 2019 to change the ins out to an mri compatible battery which the hcp believed would allow the patient to safely undergo an mri.The patient underwent a revision and replacement of the ins on (b)(6) 2019. the hcp replaced the ins but not the leads.The patient later underwent an mri on (b)(6) 2019 of the lumbar spine without contrast during which the patient experienced burning pain in her neck and back as well as at the peripheral lead sites.The patient was informed on (b)(6) 2019 that the hcp did not change the leads on the ins when the ins was replaced and the leads were not mri compatible.The hcp did not replace the leads at the time the ins was replaced because it was not his specialty.On (b)(6) 2020 the patient underwent surgery to have the entire system, ins and leads removed due to ongoing pain.After the surgery, the patient was informed that the leads were damaged, fractured, singed and one lead had snapped.(b)(6) 2021 legal, legal 1, legal 2: no new information.

• 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: 11605550
• MDR Text Key: 251349160
• Report Number: 3004209178-2021-05359
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2021

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: 03/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/01/2021
• Date Device Manufactured: 03/28/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR