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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Distress (2329)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 97715, serial# (b)(4), implanted: (b)(6) 2018, product type implantable neurostimulator reference regulatory report # 3004209178-2018-14088 for information regarding the patient's other ins.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via the manufacture representative regarding a patient implanted with an implantable neuros timulator (ins).It was reported that one of the patient's ins' intensity drops to zero when they recharge it.The patient then has to 'reset' the ins.The patient was educated on how to use the controller and to charge before the ins discharges.The patient expressed frustration that they need to be assisted with resetting intensity parameters, and not knowing what the intensity setting was.The rep was to meet with the patient at the hcp office on (b)(6) 2018 to address the issue.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 97745, serial# (b)(4), product type: programmer, patient; product id: 97745, serial# (b)(4), product type: programmer, patient; product id: 97755, serial# (b)(4), product type: recharger; product id: 97715, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator; product id: 97755, serial# (b)(4), product type: recharger.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received reporting that the one of the patient's 2 controllers (ptms) kept getting a no device found message and would only connect to the implant when attached to the recharger to charge.Without the recharger attached the ptm wouldn't work.The battery pack was removed and reinserted but it didn't seem to help.They stated this only happened with their right side implant.The patient also stated that they sometimes felt pain when recharging, and they noticed that after recharging the ptm would reset on its own and their settings went to 0.0.The patient would have to re-enter settings and increase stimulation.This only happened when using the controller for their left side implant.The patient met with a manufacturer representative (rep) on (b)(6) 2018 and was instructed to call in for replacement ptms.No out of box failure was reported, and replacements were sent.On (b)(6) 2018, the rep reiterated that the patient was having difficulty with their ptms, and noted the ptm would not connect even when held next to the hip where the implant was located.No further complications were reported or anticipated.

• 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: 7629298
• MDR Text Key: 112468854
• Report Number: 3004209178-2018-14091
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 08/08/2018
• Supplement Dates FDA Received: 07/24/2018; 10/02/2018
• Date Device Manufactured: 04/30/2018
• 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 Age: 64 YR