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

Model Number 97715

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Overheating of Device (1437); Communication or Transmission Problem (2896)

Patient Problems Burn(s) (1757); Pain (1994); Burning Sensation (2146); Skin Inflammation (2443)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead, serial#: unknown, product type: lead, product id: 97715, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via a manufacturer representative (rep) regarding a patient who was implanted with neurostimulators for non-malignant pain and complex reg pain syndrome type i.It was reported that the patient had trunk/abdomen mri on the day prior to the report and since then, the implantable neurostimulator (ins) on the left side was really hot.It felt hot on the day prior to the report and then it felt like a burning sensation on the day of the report.The lead site on the left side was also warm.The patient stated that the ins on the right side was also hot to the touch, but not like the one on the left.The healthcare professional (hcp) was contacted who instructed the patient to turn off the ins on the left side and to ice the area.In addition, the rep stated that the patient had cervical and thoracic systems and one of them had stim that was not stronger than previously.The patient had access to the pulse width and rate, so they were going to adjust those to see if that would help.The patient also reported that their skin over the left ins was red and they only felt heat in the cervical area.It was also reported that when the patient checked the right ins, he noticed an error message under the about page: 8-(b)(6) 2019-1934 (time), 9-15, 10-pt02, 11-.It was then clarified that the error message pt02 means that the last communication with the ins was successful and there was no error.In the end, the patient was redirected to follow-up with their healthcare professional (hcp) the rep was going to try to see the patient and speak to the physician.There were no further complications reported or anticipated.

Manufacturer Narrative

For related report on the patient's implantable neurostimulator (ins), please see regulatory rep # 3004209178-2019-10296.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead; product id: 97715, serial# (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer via a manufacturer representative (rep).It was reported that the device still didn't' feel the same as it did prior to the mri.The patient said that it still hurt and it really burned at times, but it was better than it was.The patient said the skin was all better and all of the blisters appeared to be gone.The patient thought the leads moved and they needed to be reprogrammed.The patient has an appointment on (b)(6) 2019.The patient tried to charge one time and the programmer didn't recognize the battery.The antenna was unplugged and tried again and it worked.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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8644053
• MDR Text Key: 146267837
• Report Number: 3004209178-2019-10297
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Date Device Manufactured: 02/15/2018
• 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: 24 YR