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); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Overheating of Device (1437); Unstable (1667); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Skin Inflammation (2443); Ambulation Difficulties (2544)

Event Date 06/14/2011

Event Type  Injury  

Event Description

The consumer reported that the patient had issues with the battery since the battery was six months old.It would take 7-9 hours to get it fully charged.The next day it would be discharged even if the stimulator was off the whole time.The patient stated at one time she spent 9 hours in the doctor's office with the manufacturing representative and got it charged and by the next afternoon it was dead.The patient had lost 100 pounds and the device was causing a lot of pain so she wanted to the device removed.The patient would feel burning when charging.The implantable neurostimulator (ins) would not charge and did not recognize the charger.The manufacturing representative was called and it would take 6-7 hours to charge and it would be 3/4 charged.It would not stay charged for 24 hours.The patient decided to shut it off completely and looked to get it removed.The battery has shifted under the skin and it was very painful.It flipped sideways and laid more at a t and poked out.It did not lay flat.It was creating problems for being mobile.Relevant medical history included: postlaminectomy pain.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the consumer on (b)(6) 2016 reported that the patient had trouble recharging the ins since three weeks after implant in (b)(6) 2010 ((b)(6) 2011).In addition, the patient had to charge her ins for 6-9 hours daily since (b)(6) 2013, and the patient was getting blisters on the ins site from recharging too long.There was a loss of stimulation and the implantable neurostimulator (ins) had not been functioning for the past 2 years (since 2014).It was noted that the patient was working with the healthcare professional to have the device taken out.It was also reported that the patient needed an mri of the cervical and lumbar spine; the reason for the mri was related to the device/therapy.The reported symptoms were considered a gradual change in therapy/symptoms.It was noted that the patient was no longer using the therapy.

Manufacturer Narrative

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

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5654790
• MDR Text Key: 45198270
• Report Number: 3004209178-2016-09496
• 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,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Date Device Manufactured: 10/19/2010
• 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): Required Intervention
• Patient Age: 43 YR