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

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359); Diabetic Ketoacidosis (2364); Reaction (2414)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a health care provider (hcp) and consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was noted that the patient¿s medical history includes diabetes.A diabetic insulin pump was noted to be in use and had been used prior to scs implant.It was reported that the patient was still in the hospital after implant.The implant occurred on (b)(6) 2017.¿something happened¿ and the patient got really sick.The patient went into diabetic ketoacidosis and became dehydrated.It was confirmed that prior to the ins implant, the patient had diabetes and an implanted insulin pump.It was requested that a manufacturer representative program the patient¿s implantable neurostimulator (ins).The patient could not find that card that they were given by the manufacturer representative.Additional information was received from the hcp on (b)(6) 2017 reporting that the implant was not the cause of the patient¿s admission to the hospital.The patient was a brittle diabetic and had a reaction to steroids given in the emergency room for their pain.The steroids started the patient¿s problem with an increase of blood sugar.The implant was reported to be stable and was not the source.It again was clarified that the cause of the issue was the patient¿s pain control and not the stimulator.Actions taken that resolved the diabetic ketoacidosis, dehydration, and sickness were admission to medicine service, insulin, and dietary restriction.Patient weight was provided.No further complications were reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury.If information is provided in the future, a supplemental report will be issued.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7118447
• MDR Text Key: 94881841
• Report Number: 3004209178-2017-26013
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 12/22/2017
• Date Device Manufactured: 10/17/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 75