MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problems Energy Output To Patient Tissue Incorrect (1209); Overheating of Device (1437); Unstable (1667); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Pain (1994); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

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 was implanted with a neurostimulator for other pain indications ¿ other.It was reported that the patient rolled over onto her back and laid there for a minute.She started feeling the ¿battery¿ getting hot.She rolled off it and it hurt and she had a constant pain.It was really burning.The next morning, she looked at herself and the top of her hip in the mirror, and it felt like ¿it¿ was lying right on her spine.She also saw bruising on both sides as big as quarters and more.She can feel it ¿sticking,¿ and it is a big hard block there on top of her hip.She has lots of problems with pain and ¿stuff¿ there.This was noted to have occurred during the winter ((b)(6) of 2017).A few months prior to the report, the patient thought that her neurologist did an ultrasound.They said that she still had ¿some muscular thing¿ and ¿it¿ is not right against the spine.The patient was wondering if the ¿battery¿ was leaking.She thought that ¿it¿ has to be leaking or something because it gets so hot when she lies on it or puts pressure on it.The patient stated that the ¿implant¿ was removed but not the ¿battery.¿ it was reviewed with the patient that the battery is the same things as the implant.The patient noted that the health care provider took the ¿implant¿ out but left the ¿battery¿ and ¿tubing¿ in there all the way up her spine because the battery was good for 7.5 years.[this information was confusing.] the patient noted that she can feel the back of her hip from the scar tissue.Bruising was also reported.The patient said since the health care provider ¿left all of that crap¿ in her body, now, 14 years later, there is always a bruise.When she wears jeans and stuff, it is bruising.Additionally, it was reported that the patient was in pain for so many years.Now finally the bad pain is gone, but if she lays on the back of her head or lies wrong at night, her head just shakes.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that there were 4 implants put in the patient¿s back and not one of them helped.The patient said they gave them lots of scar tissue in the back of the patient¿s ear and head.The battery was reported to turn on at night and it got so hot and it burns the patient.The patient said that this wakes them up.The patient said there was a constant pain.The battery was said to be 7.5 years old.The patient said the only thing that could help is to take it out.The patient said the issue wasn¿t resolved, but the battery was going to be taken out fast because it pushed against the patient¿s spine and the patient can¿t stand straight.The patient saw a neurologist who took an x-ray and told the patient it was not on the spine.The patient said they can¿t find a doctor that will touch the device.The patient said they had an appointment on (b)(6) 2018, but the patient thought the doctor would not do it (take the battery out).The patient said if the manufacturer could find her a doctor that would be great.The patient called another doctor who they saw several years ago, and the doctor said they couldn¿t help the patient anymore.The patient said the battery was coming out one way or another.The patient said they were still having all kinds of problems and all kinds of trouble.The patient¿s neuro doctor was to get a myogram of the patient¿s head, but they couldn¿t because the battery was too close.The patient said it happened to be tilted in their hip and it is turned sideways in the hip and was always bulging out.The patient said they can tell that battery and stimulation system should have never been left in for 14 years and it had been 14 years of hell.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 patient.It was reported the patient did not know the cause of the device tilting.She has not spoken to an hcp since 2010.The hcp told her they had no idea why it happened.Patient has had a gall bladder surgery a week ago and is recovering from that.Patient confirmed that the surgery was unrelated to the device or therapy.Patient does not have a managing hcp still but stated that dr.(b)(6) or dr.(b)(6) may have to take the device out because they implanted it.The devices have not been explanted yet.No further complications reported/anticipated.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7382650
• MDR Text Key: 103874138
• Report Number: 3007566237-2018-00924
• Device Sequence Number: 1
• Product Code: LGW
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2018

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 Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 03/23/2018; 04/05/2018; 06/13/2018
• Supplement Dates FDA Received: 03/29/2018; 04/26/2018; 06/20/2018
• 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: 74 YR
• Patient Weight: 73