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 Device Overstimulation of Tissue (1991); Respiratory Distress (2045); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that they had an appointment to match their settings to their body position but the issue was not resolved.They would occasionally feel stimulation very strong and would get a strong pulse to the level of their diaphragm.This made the patient feel like they couldn't move or breathe.This problem would persist until the patient could reposition their body.The patient could not feel comfortable stimulation because of the strength of the pulse.It was noted that the patient felt better without all the problems.The patient turned their stimulation off and the issues resolved.The patient was implanted for spinal pain.No interventions were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Event Description

Additional information received from the manufacturer representative (rep) in response to follow-up reported that the issues were resolved.

• Brand Name: RESTORE SENSOR
• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5510916
• MDR Text Key: 40856120
• Report Number: 3004209178-2016-04915
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2016
• Date Device Manufactured: 03/13/2012
• 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