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

Model Number 97716

Device Problems Break (1069); High impedance (1291); Application Program Problem (2880); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 09100-60, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative [rep], foreign) regarding a patient who was implanted wi th an implantable neurostimulator (ins) for unknown indications for use.It was reported that there was high impedance causing out of regulation (oor).The patient had very strong settings and possibly something wrong with lead number 1.Electrode 1 was broken and sometimes in warnings.The system also talked about electrodes 0, 1, and 2.A device data report and session report were provided with a request to investigate.It was noted that the oor was triggered by certain at specific body positions.Additional information was received from the rep.It was reported that the impedance used for therapy were all between 1220 and 1600 ohms.It was noted that the patient was not involved in any accident/sporty activity, but that the attacks the patient had could result in him making sudden movements.The patient also would twist his neck a lot to feel the paresthesia throughout his entire head.It was noted that this could be an influence for the open circuit.Additional information was received from the rep.It was reported that the rep first visited the patient on (b)(6) 2021, and later visited on (b)(6) 2021.The serial number of lead number 1 was unknown, and the implant date was in january of 2019.The patient experienced insufficient pain relief as a result of the oor and high impedance.Contact with the manufacturer's technical services was made along with an attempt at reprogramming.It was noted that this information was confirmed with the physician/account.

• 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: 11852823
• MDR Text Key: 266979520
• Report Number: 3004209178-2021-08005
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Date Device Manufactured: 10/08/2020
• 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