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); Inadequacy of Device Shape and/or Size (1583); Unexpected Therapeutic Results (1631); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Electromagnetic Compatibility Problem (2927)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/13/2019

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 patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient didn¿t like their new implantable neurostimulator (ins) and the external components and wished he could go back to their previous system.The patient noted that it takes too long to charge, the ins charge only lasted for three days, he had to charge it two times a weekend, and he had to charge the controller more often too.The new ins was heavier, it was not the same as the old system which the patient preferred, but ¿the new system did what it was supposed to.¿ the patient stated that his pain kept coming back in different places and he was up all hours of the night adjusting the stimulation.On (b)(6) 2020, the patient added that the new system did not have as much coverage areas and it did not do the same features that the old device did.The patient also mentioned that h e wanted the programming to be on the low end, so he experienced the ¿pounding¿ sensation to help his pain; they did not like the high frequency settings.It was also reported that the old system was much faster, charging was faster, it would turn on faster, and operating it was faster.The patient met with a manufacturer representative (rep) on (b)(6) 2020 to ask of there was the option to get his old implant back.A rep mentioned that due to device programming limitations, the patient was unable to adjust the rate from 2-85 on his programs.In the end, the patient was redirected to follow-up with their healthcare professional (hcp) to discuss options.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer and a manufacturer representative on 2020-jan-09 reporting that the patient was dissatisfied with their current implant.It was not allowing the same parameters as their previous implant.It was reported that the patient felt that since this new implant they had taken 1-2 steps back.They relied on the implant and pain medications.It was also reported that the implantable neurostimulator (ins) was "sabotaging" their apartment.Additional information was received from the consumer on 2020-jan-27 reporting that the new stimulator did not perform as well as the patient's previous system.It was slow to turn on, slow to adjust, and slow to charge with more frequent charge times.Discussions about changing the ins to a non-rechargeable were held but the patient did not want to have more surgeries.No further complications were reported.

Manufacturer Narrative

Product id 97745, serial# unknown.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 patient.Patient repeated already reported information and also reported that the ins took 2 hours to charge up, he couldn¿t get the settings to the same level that his previous ones were set at.Patient stated he wanted the controller to stay unlocked and he wanted to be able to adjust the rate all at once.

• 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: 9570224
• MDR Text Key: 178585103
• Report Number: 3004209178-2020-00664
• 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: 02/03/2020

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: 10/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/09/2020; 01/16/2020
• Supplement Dates FDA Received: 02/01/2020; 02/03/2020
• Date Device Manufactured: 11/07/2019
• 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: 64 YR
• Patient Weight: 95