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

Model Number 97714

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Displays Incorrect Message (2591)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 07/11/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant product(s): product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

The patient reported they were in their garden bent over at the waist for maybe 30 minutes on (b)(6).Following this she had to lie down for four days until she started to feel better, and she even had to drag her garbage out to the curb.Her problem was "the crack of my butt," and it went into her leg and her leg was dead.The implantable neurostimulator (ins) was good and was on her right leg but was also going into her left leg a little bit "which was fine" but the "crack of my butt" still hurt.An allegation of stimulation in the wrong location was reported.Relevant medical history includes non-malignant pain and chronic low back pain.A request was made to meet with the manufacturer's representative (rep) who had previously programmed her during her trial so that she felt it from her toe to her neck and finger on the right side which was great coverage.The healthcare provider (hcp) reported that the patient was reprogrammed again following implant.There were no additional patient symptoms reported related to the stimulation in the wrong location.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that of paresthesia in the wrong location.The patient had a loss of stimulation and had stimulation in an undesired location which was occurring daily.The patient did not have the patient programmer with her in order to check the device.The patient stated that she does not feel it at all but contradicted this by saying she feels stimulation in the wrong location.The patient also stated that she had a failed trial but then she said her trial was great she felt it everywhere she needed it.The trial date was stated as (b)(6) 2015 then changed to (b)(6) 2015.During the trial the patient layed on her right side and she felt stimulation from her toe to her finger and it was great.The patient had issues with buttock pain and stimulation was in the vaginal area which was in the wrong location.The stimulation should be in her gluts top of legs.The patient's pain was down in her leg and in her right cheek a little bit.The patient had met with the rep twice now and has not gotten it right.The stimulation was in the wrong location and it was not turned on now at all.The patient did not feel anything and was also confused about t he meaning of the icons on the recharger and the patient programmer (pp).The patient stated that she takes oral vicodin and she could not read all of the device and pp manuals because of it.She only picked out what was important and reads that.Pt called back as she has equipment now.The patient saw a poor communication on the pp.The patient did not understand where the paddle end of the antenna was supposed to be placed and the poor communication was resolved.When pp was synced with ins the patient saw the recharge the neurostimulator now screen.The patient was confused about recharging and thought that when the implantable neurostimulator recharger (insr) was plugged into the wall and the belt was around her waist the ins was recharging.She also thought that the insr complete charge screen was the ins charge complete screen.The issue was resolved with education and the patient was able to start a charging session and had 8 coupling boxes.The patient clarified information from previous day that was reported.The trial was a success and she felt stimulation from her head to her toe which is what she wanted.Since the implant in (b)(6) 2015, the patient had not had the coverage she wants.The patient had pain in gluteal crease, and tail bone and it was not being addresses.The patient stated that she wanted stimulation in her "crack" and it was just not there.The patient stated that she did have 2 groups but now she only has 1 group and that was "a".The pp icon meaning was review with the patient.She was confused between ins and pp battery level icons.Once the patient is charged, she will call back to speak about adjusting her stimulation.The patient was now charged to 100% and she saw the neurostimulator 100% charged screen.The patient was able to sync with ins and increased the setting.The patient only has group a program 1 and no other settings.The patient does not have adaptive stimulation capability programmed yet.At this point the programming needed to be done in office.The patient reiterated that the stimulation was uncomfortable/painful when she layed on her right side when sitting.To address the issue of having stimulation in the wrong location, the device was reprogrammed which was expected after having the device implanted.There were no symptoms associated with the stimulation in the wrong location.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4977069
• MDR Text Key: 24934401
• Report Number: 3004209178-2015-15566
• 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,health professional
• Reporter Occupation: Other
• Report Date: 07/15/2015

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: 04/14/2016
• 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: 08/06/2015
• Date Device Manufactured: 05/19/2015
• 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: 00051 YR