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

Model Number 97715

Device Problems Degraded (1153); High impedance (1291); Connection Problem (2900); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 37714, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6)2020, product type: implantable neurostimulator.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 27-jun-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).The rep reported that during the ins replacement surgery on the day of the report, the healthcare provider (hcp) had a challenging time getting the left lead out of the original battery, the one that was being replaced.It was as if the lead was s tuck in the battery.The hcp successfully removed the right lead out of the battery.The rep reported that the hcp eventually got the left lead out and it appeared as though the lead had eroded inside of the battery.The hcp made several attempts to reinsert the left lead into the new ins with little success.The rep reported that the hcp attached the right lead to the new battery successfully.The rep reported that part of the left lead was in the battery and part of it was out.An impedance check was done and the right lead had no impedances, but the left lead had impedances from 0-8 minus electrodes 0 and 5.The rep reported that after the replacement surgery, they programmed the patient in post-operative and was able to achieve good bilateral coverage for him despite almost the entire left lead not functioning.The rep noted that the old ins didn't have any impedances and although there was obvious erosion on the left lead in the battery, it was still functioning properly.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep and it was reported that the impedances on the lead that was not able to be inserted all the way into the battery were all over 10,000 <(>&<)> displayed the color red, indicating the electrodes should not be used for programming; however, there were two electrodes on that lead that could be used.The rep does not have possession of the replaced ins and the main issue was with the leads, not the ins.The patient is doing very well.The rep was able to achieve bilateral coverage that met the patient¿s expectations for pain relief despite having to only use one lead.The patient is very satisfied with the amount of pain relief they are getting.No further complications were reported.

• 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: 10148329
• MDR Text Key: 194963347
• Report Number: 3004209178-2020-10243
• 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,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 06/24/2020
• Date Device Manufactured: 04/14/2020
• 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
• Patient Age: 44 YR
• Patient Weight: 120