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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Pain (1994); Respiratory Distress (2045); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Numbness (2415); Skin Inflammation (2443); Electric Shock (2554)

Event Date 05/03/2017

Event Type  malfunction  

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

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient reported shocking.No falls/trauma were reported.The patient was redirected to their healthcare provider (hcp) to address the shocking.The shocking was reported in the tailbone area.The patient stated that they started getting a " real sharp electric shock when they cough or sneeze and if they use the bathroom it will really hurt.The patient stated that they feel it in their tailbone and it hurts to have a bowel movement, so they use stool softeners." the patient stated that this started 2 weeks prior to the call on (b)(6).The patient stated that they met with a manufacturer's representative (rep) on tuesday or thursday on the past week and they made changes and they still feel the shocks, but they are more dull now.The patient was redirected to their healthcare provider (hcp).

Manufacturer Narrative

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

Event Description

Additional information received from the consumer stated they had contacted their healthcare provider.The patient had adjustments made two times with no relief and they turned off the unit which made no difference after two days.The patient noted after the trial period they felt the effects of the stimulator 4-5 days later and since then they had started physical therapy.The patient mentioned the physical therapist thought there was a pinched nerve and the area was not visible due to the location of the hardware on an mri.The patient reported they continued to suffer pain and other effects of the implant.The patient explained they had allergies to metals and their hands had broken out with bumps that turned into blisters and became chafed and cracked.The patient also had pain in the right rear ribcage area beneath their should blade and was told that was due to muscle trauma.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that they were experiencing an extremely painful pinching and twisting about two inches to the right, from the lead on t9 and t10, below the patient¿s shoulder blade.The patient mentioned the spasms/stabbing to their healthcare provider (hcp) and they had no idea why that was happening, so the patient thought they would give it time.It was noted that the patient was recently reprogrammed for previous issues.Since then, the patient was experiencing a tight pinching and twisting that was extremely painful in the same spot, instead of the stabbing in the tailbone.It was noted that these issues started about a month prior to the date of this report.The patient added that the stabbing feeling in their tailbone ¿literally took their breath away.¿ it was also reported that if the patient had a bowel, it would be excruciating.The patient stated that they were advised to turn stimulation off but sometimes were unable to, so they would turn stimulation down and their bowel would be tolerable.It was noted that since changing to setting e, the patient was still experiencing spasms in their tailbone; however, they would keep stimulation at a lower setting so the spasms would be tolerable as well.The patient also reported that their arm started to feel numb after changing to setting e about two weeks prior to the date of this report.The patient stated that they were sure these symptoms were related to the device because they weren¿t happening prior to implant.At some point, the patient was only getting stimulation in their right side.They weren¿t getting much in their left side and nothing in their hip.It was unknown when that issue started.The patient was redirected to their hcp to have their device and leads checked.No further complications were reported or anticipated.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that group e was ¿sort of high¿ due to the manufacturer¿s representative (rep) making adjustments to help with pain coverage.Group e was too low before and it was not helping with the pain.The patient stated that appointment was in (b)(6).The patient mentioned their trial was much easier.The patient stated they were allergic to metal, latex, glue and plastic prior to getting the implant.The patient stated the glue used for the implant procedure caused them to break out in blisters on their hands.The patient was given medication to dry out the blisters, but now the skin on their hands cracks and bleeds.The patient mentioned they go to bed in gloves and medication.The patient stated the blisters will create big craters in their hands.The patient stated they read the booklet about polyurethane and thinks they are allergic to it.The patient had an allergy test years ago and was scheduled for an appointment with an allergist to address the blistering.The patient also reported when they cough, sneeze, or bend over, they have a bowel movement no matter what setting the device is on.The patient reported if they sneeze twice ¿it¿s more of an hour.¿ the patient had no new information on why they were experiencing the bowel movements.No further complications were reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6637307
• MDR Text Key: 77609504
• Report Number: 3004209178-2017-12768
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,Followup,Followup,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Date Device Manufactured: 03/23/2017
• 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