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

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Sepsis (2067); Swelling (2091); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for post lumbar laminectomy syndrome and spinal pain.The patient reported that she had to have the new implants ¿fixed¿ because they ¿messed them up.¿ the patient clarified after surgery, her right-side implant was swollen and she was in pain, so she went to the emergency room (er).The patient reported that the nurse ripped off the sutures when they ripped off her gauze.The rep reported that they gave her a shot for the pain and put on lidocaine patches.The patient reported that she waited a week and on (b)(6) 2018, she had her son come and look at the implant site.The patient reported that her son said they should bring her to the hospital.The patient reported that they tried calling her healthcare provider (hcp) first but there was no answer she they went to the er.The patient reported that the er hcp looked at the implant site and said it was healing just fine and not be concerned.The patient reported that her son asked about the red lines on her back and butt and the hcp told them it was probably from the prior tape and to go home and relax.The patient reported that her son didn¿t feel good about the situation, so they decided to go to the hcp¿s office to see if a nurse or another hcp could look at it since the hcp wasn¿t in the office.The patient stated the nurse took a look at it and was concerned, so she took pictures of the area and sent pictures to the hcp while the patient was in the waiting room.The patient reported that her stomach was queasy.The patient reported that she was told the hcp was coming back to do an emergency surgery, so she should go next door to the hospital and admit herself.The patient reported that they cleaned the ins/implant site and ¿irrigated¿ the patient¿s spine.The patient reported that her hcp told her she was a lucky lady because the red lines were blood poisoning and she could have died.The patient reported that the ins on her right side still hurt really bad.The patient described it as feeling ¿strange¿ and ¿like burning.¿ the patient stated that stimulation was off.The patient reported that her hcp gave her ice and 3 tylenol and told her to go home and put ice on it.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the hcp.It was reported that the cause of the pain, swelling or strange feeling was not determined.The patient did not have blood poisoning.Actions interventions taken were that on (b)(6) 2018, patent was instructed by the hcp to go home and ice the incision over the weekend and take it easy.The last hcp office heard, patient was doing better.Patient's weight was unknown.No further complications were reported/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: 7888839
• MDR Text Key: 120706583
• Report Number: 3004209178-2018-20976
• 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,Followup
• Report Date: 10/19/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/19/2018
• Date Device Manufactured: 08/02/2018
• 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: 56 YR