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

Model Number 97714

Device Problem Energy Output Problem (1431)

Patient Problems Fall (1848); Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); High Pulmonary Arterial Wedge Pressure (2480); Convulsion/Seizure (4406); Peripheral Nervous Injury (4414); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 01/01/2018

Event Type  Injury  

Event Description

On (b)(6) 2019, information was received from a consumer about an implantable neurostimulator (ins).It was reported that the patient was discovered that his stimulation affected his foot drop.The patient stated he had foot drop in both legs and the stimulation was making it worse in one leg.The patient stated his hcp told him that when his stimulation was high, it caused nerves in his leg to bounce and "do a happy dance" for 3-15 minutes and cause the calf to seize and muscle tighten.They stated that lower stimulation decreased the effect on foot drop, but increased the pain level.No out of box failure was reported.No further allegations/complications were reported.On (b)(6) 2019, additional information was received from the patient.It was reported that patient saw a podiatrist who sent the patient back to their neuro - having mris done.Patient had reduced the stimulation significantly.Issue was undetected while patient was taking lyrica.Patient did not know what direction this was headed.Currently, the issue was not resolved.Patient reduced stimulation which does lessen spasms.Patient provided their weight information.No further complications were reported.On (b)(6) 2022, additional information was received from a patient (pt).The reason for call was pt reported that they keep their stimulator mostly off because they developed "draft foot" in both of their feet.Pt said nobody is blaming the stimulator, but their calf muscles are getting extra stimulation and it's effecting the foot muscles.Pt said nobody wants to make any drastic statement, it is just when they turn the stimulator off they don't get as much stimulation to that nerve and muscle.Pt said by keeping the stimulation off, they don't trip and fall all the time.Pt said there was a history of this in their file; pss found rtg0084183 for report of uncomfortable stimulation but didn't see any other report of this in cmf.Pt said they got the implant in (b)(6) 2016 and they lost 60 lbs in 6 months and everything was going wonderful and then they started falling and not noticing problems with their feet.Pt said it took a couple of years just to figure out that maybe it was just being overstimulated; pss understood "it" was the ir calf muscles.Pt said they have some type of muscular/vascular issue that the stimulation aggravates.Pt also mentioned speaking to legal at one point in the call and said they don't want to speak to them again.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13317441
• MDR Text Key: 284731386
• Report Number: 3004209178-2022-00970
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2022
• Date Device Manufactured: 09/21/2016
• 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
• Patient Sex: Male
• Patient Weight: 89 KG