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 Unintended Collision (1429)

Patient Problems Diarrhea (1811); Complaint, Ill-Defined (2331)

Event Date 12/06/2016

Event Type  malfunction  

Event Description

A patient reported they had a fall about 2.5 weeks prior to the report.They shut their implantable neurostimulator (ins) off and did not pay any attention to it.They checked to see if it had changed and it was still showing off.The patient was in rehab for their broken hip, that was related to the fall.On the day of the report, the patient started experiencing problems with their bladder and bowel.They said it was like irritable bowel like diarrhea and then bladder and bowel spasms.It was reviewed that the device would not cause bladder or bowel problems.The patient then stated "are you sure", "what if the ins came loose".It was recommended that the patient follow up with their healthcare provider (hcp) to have the device checked.The ins was indicated for spinal pain.

Manufacturer Narrative

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

• 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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6216867
• MDR Text Key: 63690511
• Report Number: 3004209178-2016-27485
• 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: 12/31/2016

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: 08/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: 12/06/2016
• Supplement Dates FDA Received: 09/28/2017
• Date Device Manufactured: 09/20/2012
• 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 Age: 70 YR