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 Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Effects, Unexpected (2099)

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 representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for chronic low back pain.It was reported that the ins was going to be replaced, but it was in overdischarge.No symptoms were reported.No further complications were reported.Follow up was conducted.Additional information was received from the manufacture representative (rep) on (b)(6) 2018.The device was replaced due to a normal end of service (eos) being reached.The device was explanted and the leads were because it was not therapeutic for the patient.The patient met with an unknown rep last year to trickle charge the battery.The cause of the overdischarge was due to patient usage.When the patient was informed of battery replacement they stopped charging and using their device.This information was confirmed with the physician.No further complications were reported/are anticipated.

Manufacturer Narrative

Concomitant product(s): product id: 37712, serial# (b)(4), product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacture representative (rep) on 2018-jun-14.It was clarified that the patient had two batteries.So reassessing previously reported information it was determined that one of the devices was replaced due to a normal end of service (eos) being reached and the other ins was explanted.The one battery was replaced on (b)(6) 2018.The customer discarded the devices.It was unknown what the patient¿s weight was at the time of the event.It was unknown when the patient not receiving therapeutic effect began.This information was confirmed with the physician.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: 7603009
• MDR Text Key: 111107674
• Report Number: 3004209178-2018-13475
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2018
• Date Device Manufactured: 04/08/2010
• 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