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

Model Number 97715

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Bacterial Infection (1735); Pain (1994); Sleep Dysfunction (2517); Fluid Discharge (2686); Insufficient Information (4580)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt stated she wants to make a formal complaint about her implant surgeon.Pt stated she warned healthcare provider (hcp) about using morphine and she cannot tolerate it but he gave it to her anyway.Pt stated she did not eat or sleep for several days because of that.Stated hcp put the ins so close to her "crack" on her "rear-end" that the pain never left from the day she was implanted (b)(6) 2021.She complained about the ins placement from day 1 post implant and the surgeon told pt that it is in the perfect place and would do nothing about it.Her pain management hcp felt it was not in a good location so revised the implant last month (b)(6) 2021.She was diagnosed with a staph infection (b)(6) 2021 - pt stated stuff was coming out of the incision site and her hcp was able to do a swab and check it - pt stated she felt symptoms starting (b)(6) 2021.Pt feels that the staph infection was caused from the ins being in the wrong location for so long so she blames the staph infection on the surgeon who did the original implant.Pt is on antibiotics still.Pt stated that she has no complaint about the pain stim ins or the therapy.She is happy with the device but wants to make sure the hcp is reported the patient was redirected to their healthcare provider to further address the issue.

Event Description

Additional information was received.It was reported the patient's surgeon put the battery so close to the patient's crack that it rubbed on bones and tendons and gave them the infection.It was reported the issue was resolved.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported the patient had a staph infection and had called back to state everything was okay.The patient stated again their surgeon did not listen and implanted their ins next to the crack in their butt and it sat there for 7 months.The patient believed something had been rubbing and that was what caused all of the problems.The patient's healthcare provider stated it was in the perfect spot and the patient stated they did not believe it was anyone's fault.The patient stated they had gained from 115 to 135lbs because they were at home doing nothing and could not get off the couch.The patient noted they were back down to 110-115lbs.The patient mentioned that now in the area where the surgeon had to do the cord at the end in the middle right next to their bra strap, there was a big knuckle sticking out of the back and rubbing against.The knob was bothering the patient and the patient was skinny and did not have enough muscle to protect it on the other side.The patient noted they did not think to tell their healthcare provider to not put it on that side.They noted they needed to work out and was starting to do stretches and things and was going to do aquatic and massage therapy.It was noted that the last two surgeries the patient had in the last 6 years showed the patient how to work out.The patient noted the massage would help the muscle and where the wires were.The patient stated they were never out of pain with the battery.It had hurt the same day it went in.They had redone it and did and good job and it was right where it was supposed to be.The patient noted their healthcare provider gave them morphine and the patient could not eat or sleep.The patient stated in regards to the staph infection they were sick for 2 days.It was swollen on the side but the patient believed the implant site was supposed to be swollen.The patient then noticed a little pinhole in the suture and the patient got their shirt wet when they went to lay down in bed.The patient started to push on that side of the battery through the scar and the patient stated that you would not believe what was coming out of them.When the patient go to the hospital the next day the patient did not have a fever.The patient noted if they did not squeeze a little drop out of them for a culture they would never have known the patient had staph.They left the patient at the hospital but the patient was good after that.The blood work came back with no infection or fever.They noted that everything was now fine.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12523168
• MDR Text Key: 274075524
• Report Number: 3004209178-2021-14337
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Date Device Manufactured: 01/25/2021
• 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; Other; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 50 KG