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

Model Number 97715

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Seizures (2063); Discomfort (2330); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that patient was done under general anesthesia.To identify lead positions, collision studies were done and left and right to determine bilateral coverage of each lead.After collision studies and battery was be being implanted, impedance reading were attempted but the controller and communication had locked up.Manufacture was contacted to determine the communicator needed to be recycled to reset communication.After 2 attempts were done they were successful and impedance determined to be within normal limits.The device was not further interrogated ad per normal protocol, since it was felt the device was shut off.The next day the hcp to contact patient.It was determined that the device was left on high amplitude causing patient great discomfort till he was able to grab his communicator and discontinue stimulation.Factors that may have led or contributed to the issue is either the lock up prevented the return of the 8-15 channel from returning to 0, as rep felt he returned it to 0.Or it was operator error and was not returned at all.However, it seemed that was the last thing rep did to noting the lock up was returned to 0, but one way or the other the device was left on causing the patient discomfort till he could turn it off.Patient was contacted and will be seen for post off soon.The issue was resolved at the time of this report.No surgical intervention occurred or planned.Additional information was received from the patient.Patient started the was "shocked to death for 10 hours" they put the stimulator in and when patient woke up it was shocking them and patient is convulsing and shaking back and forth and it hurt so bad they could not even go to the bathroom.Patient eventually turned stimulation off last night from this report and the shocking stopped as soon as they turned it off.Patient said that the rep was not there when this started and the hcp told them not to turn it on for 2 weeks, but patient says that when he woke up from surgery the stimulation level was all the way up and the patient was shaking like crazy.Patient stated they said it was normal.Patient was advised to follow up with health care professional (hcp).No further patient sympto ms or complications were reported in this event.

Manufacturer Narrative

Product id 97745 lot# serial# (b)(4) implanted: explanted: product type programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep.It was reported the cause of the controller locking up was not determined.Rep stated the cause of the high amplitude and shocking was either operation error on last command to 0 amp did not go through as communicator had already locked up.Patient was contacted but patient had discontinued stimulation already.The ins is off.Rep trying to get withhold patient sooner than post op visit.No patient symptoms or complications were reported in this event.

• 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: 8103263
• MDR Text Key: 128322318
• Report Number: 3004209178-2018-26222
• 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
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2018
• Date Device Manufactured: 08/30/2018
• 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 Outcome(s): Other
• Patient Age: 52 YR