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

Model Number 37714

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.The patient reported a sudden loss of stimulation, noting that he was no longer felt the ¿pulsing¿ that he used to and it ¿doesn¿t feel like the system is really working.¿ the patient reported that he tried ¿boosting it up¿ from 4.10v in the upright position to 5.20v, but he still felt nothing.No other programming adjustments had been made.The patient programmer showed that stimulation was on.The patient confirmed that stimulation was on and upright to 4.10v.The patient reported that he¿s been out on his tractor in the field and that this could be rough at times and bounces him around and could be related to the issue.No further complications were reported.

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.The patient reported a sudden loss of stimulation, noting that he was no longer felt the ¿pulsing¿ that he used to and it ¿doesn¿t feel like the system is really working.¿ the patient reported that he tried ¿boosting it up¿ from 4.10v in the upright position to 5.20v, but he still felt nothing.No other programming adjustments had been made.The patient programmer showed that stimulation was on.The patient confirmed that stimulation was on and upright to 4.10v.The patient reported that he¿s been out on his tractor in the field and that this could be rough at times and bounces him around and could be related to the issue.No further complications were reported.

• 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: 7664898
• MDR Text Key: 113266992
• Report Number: 3004209178-2018-15102
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2018
• Date Device Manufactured: 04/20/2013
• 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 Age: 78 YR