MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SPINAL CORD STIMULATION LEAD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_UNKNOWN_LEAD

Device Problem Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Viral Infection (2248); Complaint, Ill-Defined (2331); Peroneal Nerve Palsy (2362); Impaired Healing (2378); Ambulation Difficulties (2544)

Event Date 01/07/2013

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: neu_ens_stimulator, product type: external neurostimulator.Product id: 74002, lot# n267578, implanted: (b)(6) 2011, product type: adapter.Product id: 37712, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 3550-29, lot# n297233, implanted: (b)(6) 2011, product type: accessory.Product id: 355531, lot# n308086, implanted: (b)(6) 2011, product type: screening device.Product id: 3778-75, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 8591-60, lot# d01051, implanted: (b)(6) 2011, product type: accessory.Product id: 37743, serial# (b)(4), product type: programmer, patient.Product id: 37752, serial# (b)(4), product type: recharger.Product id: 37092, lot# 299270002, implanted: (b)(6) 2011, product type: accessory.Product id: 3550-39, lot# n303110, implanted: (b)(6) 2011, product type: accessory.(b)(4).

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for non-malignant pain and failed back surgery syndrome.It was reported that the patient had a trial for the right arm, something happened, and now the patient was having stomach pain.The healthcare professional healthcare provider (hcp) had put in one lead and the patient had wanted two leads.The stomach pain started during the trial, and the pain was still ongoing.It was noted that the patient did not have any issues with the implant, just the trial.More than 2.5 years later additional information received from the consumer reported that the hcp that did the trial did some damage.No outcome was reported for this event.It was later reported that when the doctor began to insert the lead he ran into some resistance and the wire would not proceed further.The patient began to complain about the pain and they gave her some additional iv medication.It was still hurting and she received more pain medication.The doctor continued to push until it passed through the area.The doctor repeatedly was asking if this was the way the manufacturing representatives (rep) did it.The doctor was new and possibly had not worked with these reps before.After the procedure the patient immediately had diarrhea and continued to have it through the duration it was in.Her blood pressure also increased due to the acute pain she was having in her stomach area and back.When the wire was withdrawn the same intense pain was repeated and she continued with diarrhea.Over the weekend she did not get any better and they made an additional appointment with the doctor.He told the patient that she had the flu.A rep explained that the wire scraped along a bundle of nerves against the spine.In time it would heal.When the wire came out, it repeated the process.She had such an elevated pressure that they worked with the programs enough that they were able to get some of the leads to give her some stimulation in the stomach area even though they were in her neck.She had tried to have tests run in this area and there was not one doctor willing to try to help.She always received the answer "we can put another lead in.Her answer to that was no.It would leave her with more scar tissue and possibly more damage to peripheral nerves.The patient was not well.She had a constant burning feeling like a bad sunburn across her stomach.The nerve bundle that was scraped and damaged never healed and she had a constant problem with the psoas muscle which caused the sciatic nerve to get pinched.This reduced her walking and bending activities.She learned about releasing or trying to release the muscle through physical therapy (pt).It was not easy to work with and she was on a higher dose of pain medication and took more gabapentin.All the medication was causing more bowel problems.She ordered her first cane yesterday because she could not pivot when she got up to walk.Another stimulator would never be a solution for her.Not because she disliked the product, but because it would not necessarily resolve the muscle problem.They had become weaker and had made the right leg slightly longer and her foot dropped (pt explanations).A manufacturing representative (rep) later reported that she had had reprogrammings that were all satisfactory to his knowledge.

• Brand Name: SPINAL CORD STIMULATION LEAD
• 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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5345073
• MDR Text Key: 35092702
• Report Number: 3007566237-2016-00033
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2013
• 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): Other
• Patient Age: 00043 YR