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); No Device Output (1435); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Weight Changes (2607)

Event Date 05/03/2013

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 consumer regarding a patient with an implantable neurostimulator (ins) for cervical/neck and spinal pain.It was reported that the patient got some stuff put in his neck that is working great, so he doesn¿t need the stimulator anymore.The patient hadn¿t used the stimulator in a year and it bothered him to have something in his body that he was not using and no longer needed.It was also mentioned the patient lost some weight.The patient said the wires run up his neck and the battery is in his side.The patient said they cut him from his crown through the edge of his back and stretched him up.The patient understood that they put some gold strips in there and the wires ran to it and screwed it and glued it.Later in the call, the patient said there were thin metal strips in his neck.The patient also reported because of placement, it moves.The patient said during implant surgery, he was dropped off the table and injured.The patient had hep c and spent 10 days in the hospital.The patient said his shoulder was m essed up.The patient said that the stimulation caused muscle spasms on a regular basis.The patient also said the ins went dead and the patient could not recharge or turn it back on.The patient said he let it go dead once.The patient said he had an appointment with his healthcare provider in the afternoon of (b)(6) 2018.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 on 2018-may-29.The patient noted having their medical records and would be happy to share with the manufacturer.They also have their liver test before and after surgery.The patient wishes that the manufacture representative (rep) could visit their area hospital.Their weight went up to (b)(6) and now they are at (b)(6).When asked for circumstances of their issue the patient stated that the placement of the device was always hard to charge.They had to make the belt very tight to get the proper signal.They cannot explain the muscle spasms.They just had them until they tried shutting the device off just to see what happened.For the first year they kept it turned up high to help their shoulder.They have to take blame for theins not turning back on because they let the battery get too low.They are sure.Their activity level is lower now than before surgery.It is 4 hours to a rep.They cannot afford to go and don¿t have a car anymore.They were hospitalized for 4 days after surgery.They were supposed to go in on the 3rd to get out next day by their doctor.They discharged them (b)(6) 2013, they were not ready.They had a 4 hour ride home.It was bad, next day they had issue so they went to the local hospital on (b)(6) 2013.They would not touch the patient and told them to return to their doctor so they then stayed from (b)(6) 2013.Only 7 days in all.Nothing was done for the device placement.The muscle spasms are very seldom now.The ins is still dead.Ins is low and is healed now.Shoulder is weak but they just live with it.Their hospitalization was from the accident that happened in surgery.They would like the ins turned back on.They have neck pain often and lower back pain daily.They need the stimulator put in their lower back.When they asked about a structure stent from their stimulator in their neck the doctor said there would be none.They have gold strips in their neck to support it.They can tell a different from before and now.The con is that their neck is infused with the stimulator in place.No further complications were reported/are anticipated.

• 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: 7390165
• MDR Text Key: 104265503
• Report Number: 3004209178-2018-06291
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842336
• UDI-Public: 00613994842336
• 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
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2018
• Date Device Manufactured: 04/11/2013
• 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): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 112