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

Model Number 37714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

Information was received from a consumer and a healthcare professional regarding a patient who was implanted with a neurostimulator for spinal pain and chronic low back pain.It was reported that the patients device was malfunctioning and not giving the patient enough relief.No further complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient on (b)(4) 2017.It was reported that their implantable neurostimulator (ins) hadn¿t been working for a couple of years.The patient stated that they didn¿t know of any circumstances that may have led to the issue, that it just ¿quit working.¿ the patient reported that they were in a lot of pain and had sciatic nerve damage to their left side and lower back.It was noted that the issue of the ins malfunction had not been resolved yet.No further complications were reported or anticipated.

• Brand Name: RESTORE SENSOR
• 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: 6833598
• MDR Text Key: 84089341
• Report Number: 3004209178-2017-18479
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

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: 03/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 10/05/2017
• Date Device Manufactured: 04/19/2012
• 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 Weight: 61