MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3487a-33, lot#: v062562, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neuro stimulator (ins) for rsd/ causalgia-complex regional pain syndrome.It was reported that patient got a letter asking her to call in and update her information.Patient said she did not want an id card because she going to have device removed.Patient said the lead popped out of the bone in her neck and was giving her excruciating pain.Patient said if she touches it she gets a tiny little electrical charge, patient said itis not shocking or a zap.Patient said her device has been off since 2010.Patient said she had 2 surgeries then 5 more and just never turned the device back on.Patient said the device was supposed to be removed on the (b)(6) but she got sick and has to reschedule.It was reviewed once the device is removed the patient should call and update her registration.No further patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.Information references the main component of the system and other applicable components are: product id 3487a-33 lot# v062562, explanted: (b)(6) 2018- product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the consumer.It was reported that the lead shifted in their neck and protruded from the bone; it pressed on nerves causing excruciating pain and migraine headaches.The device was in their stomach and the lead was in their neck.These were removed by their healthcare provider on (b)(6) 2018.The lead caused their nerves to become irritated.Their doctor told them that the pain should diminish in several months as the nerves in their neck healed.They were still experiencing pain from the injured nerve and nerves that were cut during the surgery.They still received nerve pain shooting across their back and up to their neck.They hoped this diminished in time.They also noted that they still experienced pain in their neck due to the work related injury which was a permanent condition.No further complications reported.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7276927
• MDR Text Key: 100272526
• Report Number: 3004209178-2018-03429
• 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
• Report Date: 10/05/2018

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 Expiration Date: 12/28/2009
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 08/08/2018
• Supplement Dates FDA Received: 07/13/2018; 10/05/2018
• Date Device Manufactured: 02/10/2009
• 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; Required Intervention
• Patient Weight: 55