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

Model Number 97715

Device Problems Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)

Event Date 04/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer concerning patient with an implantable neurostimulator (ins).It was reported the patient was setting settings not available on the controller.The patient was getting this message only on group b.The patient states she uses this setting 90% of the time.The patient reported she has not been able to sleep the last couple nights.The patient was in pain and spasms in her left leg.The patient states she can use group a and c and can increase but they do not help her with the left leg, which she needs.While on the call the patient decreased down to zero and could only increase up to 0.1v before seeing settings not available.The patient also mentioned she has lost 100 pounds.The patient was redirected to their healthcare provider (hcp).No further complications were reported/anticipated.Additional information was received from the patient.It was reported that the "b" setting and main settings stopped working and showing unable to provide stimulation.Patient took out battery and turned b down to 1 and up again however received same message.Patient stated a and c were fine just not providing therapy where she needed.Patient unsure what circumstances may have led to issues however provided that they had gastric sleeve done (b)(6) 2019, and a serious fall with complications then lost over 100 lbs.Patient stated the issue was resolved after meeting with their rep.Patient reported the rep found "2 leads (electrodes) not working" and programmed around them.Patient expressed appreciation.Issue was now resolved.

• 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: 10106797
• MDR Text Key: 193742482
• Report Number: 3004209178-2020-09490
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2020

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: 04/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/01/2020
• Date Device Manufactured: 05/10/2018
• 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
• Patient Age: 51 YR
• Patient Weight: 101