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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Increased Sensitivity (2065)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer implanted for spinal pain reported they started gradually experiencing pain in their knee.There were no falls or traumas reported related to this issue.According to the consumer they may need to have a knee replacement and "i may have nerve damage down the inside of my knee, is that related to the device?" it was further stated "it's been like this, a little sensitive for the last year," and had gradually been getting worse.

Event Description

Additional information received from the healthcare provider (hcp) reported prior to implant the consumer did have a diagnosis of arthritis and an mri that showed lumbar spondylosis with left-sided disc protrusions at l3-4 and l5-s1 along with an annual tear at l4-5.Another mri also showed a rotator cuff longitudinal split with subdeltoid bursitis and glenohumeral effusion.On (b)(6) 2014 during a post-operative visit the consumer¿s pain went from an eight to a three, but they still had some lower back pain and tenderness.Additionally following the procedure the consumer¿s physical functioning, family and social relationships, mood, sleep pattern, and overall function were 70% better.During the time of the visit the hcp noted the consumer having lumbar radiculopathy and sacroilitis which was present prior to implant.

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: 6020763
• MDR Text Key: 57119249
• Report Number: 3004209178-2016-21598
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Date Device Manufactured: 11/18/2013
• 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 Outcome(s): Other
• Patient Age: 54 YR