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 Failure to Deliver Energy (1211); No Device Output (1435); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Dyspnea (1816); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 10/01/2014

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

Other applicable components are: product id: 37752, serial#: (b)(4), product type: recharger. Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead. Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead.

Event Description

It was reported that there was a communication problem. The patient went to charge the device the night prior and was unable to do so. An implantable neurostimulator (ins) overdischarge was suspected. The last time any stimulation was felt was 2 to 6 months prior, (b)(6). The last successful recharging session was 2 to 6 months prior, (b)(6) there was no stimulation sensation and the patient was in excruciating pain. The patient was unable to turn stimulation on due to potential overdischarge. When asked if pain was related to the device, the patient noted their entire body was super complicated. They had chronic lyme and major sensory issues. The healthcare provider (hcp) told the patient to turn the device off last (b)(6) the patient also worked with energy healers. The patient had an appointment set up for tuesday and wanted a manufacturer representative(rep) at the hcp office. The rep didn¿t show up for the appointment last tuesday. The patient noted they weren¿t doing anything. The patient had lyme disease and could barely function, the patient was in excruciating pain. The patient needed to have the device jump started. The rep was supposed to be there last tuesday but wasn¿t. The patient had so many symptoms because of lyme disease. The patient was suffering beyond belief and was very, very ill. The patient was in ¿agony¿ and excruciating pain. The patient would like to have the device jump started so they could get some relief in their back. The patient could barely breathe. Information regarding if an overdischarge was confirmed has been requested. Additional information received reported the overdischarge was confirmed. The patient wasn¿t using stimulation, which was what caused the overdischarge. They had not done the trickle charge yet and the patient did not want to use their stimulation yet. Additional information received from the patient reported that they no longer use their implantable neurostimulator (ins) and hadn¿t for a couple of years. The patient stated that they were not able to revive the ins from its overdischarged state, so they decided to just leave it off. It was noted that the issue occurred in 2015. It was also reported that the device never really helped the patient target pain more than 10%. The patient stated that they always had trouble charging the ins, noting that their healthcare provider (hcp) had implanted it at an angle because the patient was thin and wanted to keep it out of sight. The ins was implanted on the left hip/back area. It was noted that the patient thought the angled ins was the reason for the charging difficulty. The patient also mentioned that they didn¿t want to have the system explanted because the healing time from the implant procedure was long; it took months and was very painful for them. The patient was to follow up with their hcp, but didn¿t intend to use the device again at the time.

Manufacturer Narrative

(b)(4) doesn't apply to this event. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional review indicated the difficulty charging due to the tilted ins, lack of therapeutic effect since implant, and long healing time was not related to this event.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6312643
• MDR Text Key: 102503144
• Report Number: 3004209178-2017-02858
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/29/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial