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

Model Number 97715

Device Problems Disconnection (1171); High impedance (1291); Migration or Expulsion of Device (1395); Energy Output Problem (1431)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 04/12/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 3778-60, serial/lot#: (b)(4), ubd: 02-jul-2017, 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 is implanted with a neurostimulator.It was reported that the patient had the previous implantable neurostimulator replaced due to normal battery circumstances on (b)(6) 2020.The patient has two leads, 0-7 for cervical 8-15 for lumbar.The 8-15 lead, when used, is giving the patient groin pain, which the patient describes as ¿pinching.¿ this had been occurring since about a month prior to the report, confirmed as (b)(6) 2020.The patient has the same programming on the lead as before the surgery, and the patient has had no falls since the new implantable neurostimulator was placed.The manufacturer representative has tried various contacts on the 8-15 lead on (b)(6) 2020, and they all resulted in this pain when the implantable neurostimulator is on.Impedances looked ok on this 8-15 lead.When the manufacturer representative met with the patient on (b)(6) 2002, there was not any noticeable problem with the leads or the implantable neurostimulator.There was only one electrode with high impedance on the cervical lead, electrode 0.The thoracic lead was replaced on (b)(6) 2020.After taking an x-ray, it was visibly seen that the thoracic lead had migrated down out of place which was the cause of the groin pain.The patient has had no problems since they replaced the lead.The patient is now doing fine.The cause of electrode 0 being out of range was determined to have been something with the connectivity to the implantable neurostimulator.After the thoracic lead revision, the physician re-connected both leads and all of them have perfect impedance measurement.The 0 electrode no longer has a high impedance value.The patient¿s weight is unknown.There were no further complications reported or anticipated.

• 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: 10073443
• MDR Text Key: 192712029
• Report Number: 3004209178-2020-08842
• 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: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Date Device Manufactured: 06/10/2019
• 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: 54 YR