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 Intermittent Continuity (1121); Failure to Deliver Energy (1211); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193)

Event Date 07/31/2017

Event Type  malfunction  

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 non-malignant pain and complex regional pain syndrome type ii.The patient reported that she felt no stimulation in any position.The patient reported that normally her stimulation felt more when she leaned back or laid flat than when standing, now she felt nothing at all.The patient reported that she tried increasing in each program.The patient reported that she had 3 programs and felt no stimulation.The patient reported that she had no groups to change.The patient reported that her ins was charged and the lightning bolt was there.The patient also reported getting cramping.The patient reported that she didn¿t get pain as much but she got cramping really bad.The patient reported that if she worked and moved around it wasn¿t as bad but now the poor was closed for 2 weeks and she was not exercising.No further complications were reported.Additional information received.Patient reported that stimulation quit working, turned off came back when returned on.But wasn't consistent and stimulator varied.It was reported that the steps taken to resolve the loss of stimulation was going to the pain clinic.Patient reported don't know if needed so at present have tuned off - but keeping charged.It was reported that loss of stimulation had not been resolved.Patient reported that if they feel they need they will try again and request a technician.Additional information was received from the patient (pt).Pt reported it quit working about 4 years ago.Sometimes they would feel it but mostly it was sporadic so they shut it off.The patient kept charging it, but then they stopped and now they can't charge.Pt says she knows that she has scar tissue and doesn't want to take the stimulator out, and that is also why she thinks it stopped helping her pain because it was so sporadic, they think because of the scar tissue.It was reviewed pt was still under mri restrictions if she leaves it implanted and she says she understands this.Pt says this started happening 4 years ago but couldn't confirm for sure which year it started.It was reviewed they can follow up with healthcare provider (hcp) if they choose.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10788198
• MDR Text Key: 214800878
• Report Number: 3004209178-2020-19337
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Date Device Manufactured: 01/26/2011
• 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: 68 YR