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

Model Number 97715

Device Problems Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: 977a2, serial#: unknown, implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that electrodes 10, 13, and 15 had impedances displayed as ¿avoidance¿ and that in some cases the values ¿returned to the normal display when the patient¿s posture was changed.¿ the implantable neurostimulator (ins) session report from (b)(6) 2021 noted that electrodes 10, 13, and 15 had low impedances of 90, 90, and 200 respectively.It was stated that ¿the lead position was not at the contact position¿ and that this may have led or contributed to the issue.Clarification was sought regarding this statement; follow-up received stated that it was meant that since the three electrodes in question were on the same lead that they ¿were not in contact with each other¿ and since the patient¿s two leads were not implanted in parallel, ¿it was difficult to think that the electrodes contacted each other.¿ the patient¿s physician¿s observation about causality was unknown.It was noted that the issue was considered resolved at the time of report.There were no surgical interventions planned or performed and the intractable chronic pain patient was alive with no injury at the time of report.No complications were reported or anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12482253
• MDR Text Key: 271728193
• Report Number: 3004209178-2021-13962
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Date Device Manufactured: 08/03/2018
• 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