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

Model Number 97702

Device Problems Intermittent Continuity (1121); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

The patient wanted to know what the dangers were with the therapy and it was confirmed that he read the patient programmer (pp) manual listing the risks, precautions, warnings and potential adverse events/effects.The rate was set at 50.Program 1 was at 3.0v and the patient¿s health care provider (hcp) told him his implant would last 5 years.Normally the patient sets it at 2.5-3.0, sometimes even lower 2.1v and turns it off as he does not need it.The patient¿s hcp told him he could use it 24 hours a day if needed.One of the reasons the stimulation (stim) was put in was the pain in his right hip.The stim does not cover the hip pain unless the patient increases it pretty high (3.5-3.6v) which creates a heavy stim and makes him feel like he was going to be off balance if he walks.If the patient has to do that he gets into a recliner or lays down.The patient¿s only complaint was the stimulation was not always covering his lower back and he has to take a loratab (hydrocodone).The patient takes a loratab to help but wants to get off that because he wants to get off medications and was not supposed to be driving with that narcotic, he does not want to be in trouble.The loratab stops the patient from driving and did not know if the stim would help with that.The patient¿s hcp did not put the wires (leads) where they were touching the spinal cord or something because the patient does not have the same coverage.It was not going to be a cure all like the patient thought it might, he does not have to always take the loratabs as much, he used to take them every 3-4 hours and now can go almost 7 hours before needing one but he has been taking more of these pills lately though.The patient did not know if he would ever get back to driving and the stim has helped him better than it used to be.If the patient went back up higher 60, 70, 80 he would use his battery up faster.The patient wanted to know if he goes to 40 for the rate would he be able to crank it up higher if he needed it on his hip without a super strong vibration if he walks without his cane.The rate was originally set at 60.The patient feels a surge when he coughs.When the patient lays in bed, he lays on his back most of the time, if his head goes back parallel to his body he could feel the stim all the time but if he raises his head forward the feeling of stim goes away.The patient wanted to know if that would affect the operation overtime.The patient knew the stim did not cut off but was afraid it was affecting it someway.The patient was waiting for the detachable antenna to arrive, he lost it and it was supposed to arrive.The patient just has to remember the buttons he was pushing when he uses the pp without the antenna because he cannot see it and it comes in handy sometimes.An information request was made regarding the pp.The patient received training but he just does not recall.During the report the patient was able to increase his stim up to 3.5v and rate up to 60 but then he took the setting back down to 3.3v.The patient¿s next follow up meeting was (b)(6) 2014 with his hcp.The information request on the pp resolved the reported issue for now.Additional information has been requested.

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient; 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 later reported a month later that the patient had a 50% or greater symptom reduction.The cause of the event was not determined.Reprogramming was needed.The patient was seen in the office on (b)(6) 2014.The patient was reprogrammed to provide the best possible pain relief, however, the stimulation did not reach his right lower back and buttock.The doctor was made aware of it.The doctor was going to discuss a possible lead revision at the patient's next visit which was in mid-september.The impedances were within normal limits.The patient seemed satisfied with the doctor's plan of waiting until his next visit in september to discuss any further action.The stimulation does cover bilateral hips to calves.

Manufacturer Narrative

(b)(4).

Event Description

The patient later reported about 3 weeks later that he still had concerns regarding his device or therapy but was working with her doctor or company representative.The device works well for the most part but the right hip was still painful without pain medications.An appointment of (b)(6) 2014 was noted.

• 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: 3912727
• MDR Text Key: 4582689
• Report Number: 3004209178-2014-12498
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2014
• Date Device Manufactured: 05/21/2013
• 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: 00073 YR