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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Wound Dehiscence (1154); Muscle Weakness (1967); Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); Electric Shock (2554); Fluid Discharge (2686)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c165, serial#:(b)(4), implanted:(b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 04-dec-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who is implanted with a neurostimulator.It was reported that the procedure to get the implantable neurostimulator implanted ¿about killed him¿, noting that it took the health care professional 5 hours to put the implantable neurostimulator in.The patient could not walk or move after the surgery and had to go to rehabilitation to get his strength back.The incision from the surgery was open, leaking, and draining fluid.The patient noted that the experience was a major nightmare.The implantable neurostimulator was removed because it never helped the patient with pain and ended up causing the patient more pain.The leads moved and went through the patient¿s nerves causing shocking in the patient¿s stomach.The patient could not be programmed because of this.Additional information was received from a health care professional regarding the patient on (b)(6) 2020.It was reported that arachnoiditis, tobacco dependence and bipolar illness were factors that contributed to the difficult implant surgery.Additionally, it was noted that the description of the event previously reported was not accurate.Clarification of this was not received.There were no further complications 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10279288
• MDR Text Key: 199129243
• Report Number: 3004209178-2020-12262
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Date Device Manufactured: 06/22/2018
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 132