MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/16/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

Event Description

It was reported that there was a loss of stimulation and therapy in (b)(6) 2015.The patient stated that the stimulator felt liked it worked on the left side, but not the right side.This had been happening for about a month.The patient programmer (pp) showed that the stimulation was on and the patient had the ability to change the stimulation.The patient had a stroke on (b)(6) 2015 and has been falling lately since then.This may be possibly related to the issue.The patient visited the healthcare provider to address the falling.The patient had been falling on the back and stomach.The patient stated that the stimulator was not working correctly.No interventions or outcome 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

It was reported that there was a loss of stimulation and therapy in (b)(6) 2015.The patient stated that the stimulator felt liked it worked on the left side, but not the right side.This had been happening for about a month.The patient programmer (pp) showed that the stimulation was on and the patient had the ability to change the stimulation.The patient had a stroke on 2015 (b)(6) and has been falling lately since then.This may be possibly related to the issue.The patient visited the healthcare provider to address the falling.The patient had been falling on the back and stomach.The patient stated that the stimulator was not working correctly.In addition, in (b)(6) 2015, the patient stated that the programmer was "stuck on a, like i'm laying down and it keeps turning off".This has been happening for the last week or so according to the patient.The patient saw the hcp "and he felt the stimulator and said everything is ok".The adaptive stim (as) was disabled since it was stuck on "lying", and the patient could now manually change the settings.It was suggested that the patient consult wit the hcp and ask that a rep be at the appointment so they could check the stimulator settings.No interventions or outcome 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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported they were not sure why the programmer was stuck but the representative reprogrammed after about 30 minutes of working with them.The stimulation was not hitting or working on the patient's back or legs; just made their stomach really strong.All spots were reprogrammed.If additional information is received, a follow-up report will be sent.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 5077878
• MDR Text Key: 26176897
• Report Number: 3004209178-2015-17968
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Report Date: 08/21/2015

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: 09/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Date Device Manufactured: 11/08/2013
• 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: 00044 YR