MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37711

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Type  Injury  

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins).It was reported patient had her implant removed because it wasn¿t working properly and it had been in her ¿tip¿ for several years.Patient quit using it because it wasn¿t helping, but the implant decided to turn itself on whether the implant was charge or not, the patient would get a little jolt.Patient went to neurosurgeon and got everything checked out, had whole thing removed because she wasn¿t using it anymore about a year and a half to 2 years ago.Patient didn¿t remember the name of the doctor that took out the implant.It was mention patient had device removed and would like to donate desktop charger.No further complication and events were reported.

• Brand Name: RESTORE
• 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: 7203740
• MDR Text Key: 97707774
• Report Number: 3004209178-2018-00936
• 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
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2007
• Device Model Number: 37711
• Device Catalogue Number: 37711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/18/2018
• Date Device Manufactured: 06/05/2006
• 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