MAUDE Adverse Event Report: MEDTRONIC INC. INTERSTIM NEUROSTIMULATOR MODEL 97810; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 97810

Device Problems Energy Output Problem (1431); Charging Problem (2892); Temperature Problem (3022); Wireless Communication Problem (3283); Patient Device Interaction Problem (4001); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Type  Injury  

Event Description

I currently have a medtronic interstim neurostimulator model 97810 which was implanted in me on (b)(6) 2021.It is defective in so many ways that it beggars belief.I was assured by medtronic rep prior to surgery that this device that would last 10-15 years and require charging merely 30 minutes per week.Specifically, the many problems that i have had, and continue to have, with this device are as follows: 1.When i do my weekly recharge, the recharger does not recognize the implanted device most of the time.The connection is lost at least 6 times during the session when i try to recharge.I have to stand and hold the recharger directly on top of the device and it still will lose the connection multiple times and wait for several minutes whilst it looks for the device.I am unable to sit down whilst recharging takes place as the device won't be able to find the recharger if i do.Wearing the wrap with the recharger over the device makes no difference at all ¿ in fact it makes it less able to sustain a connection.The recharger will be directly over the device and it still cannot make the connection.It is a constant battle.I am 53 years' old, 5' 10", 150 lbs, in no way overweight nor technically a dinosaur.I know how to handle electronics and where to place the recharger.However, the recharger and the phone device ¿ fail to recognize each other or their connection much of the time and lose the connection multiple times when they finally do 'connect'.2.The time to recharge generally takes me at least over 1 hour 15 minutes per week (even if recharging from a position of 40% battery charge) and has, several times, taken over 2.5 hours to recharge, with me standing at a strange angle holding the recharger in place in order for the devices to recognize each other to attempt to maintain a connection.There is no reason i should have to stand in place for 2.5 hours whilst the device recharges.I have never let the battery get to zero percent.3.The recharger causes a stinging/electric shock on the skin whilst recharging is taking place that is very painful and it makes the recharge sessions extremely uncomfortable because the skin gets hot as the device is recharging.It shouldn't be causing a patient pain to recharge the device.4.The device, on 4 occasions so far, has had a "por" event where the phone tells me "por has been detected" and recharging ceases.Both the recharger and the phone communicator/programmer stop working and freeze.I then have to switch everything off, wait several minutes and then attempt to turn both back on again.The main programmer stalls at this point.5.The device also has had an event once which was either "1707" or "1727" where the surface of my skin got really hot again, the device and recharger then stopped working and the phone communicator showed a message with that code stating that i needed to contact my provider.It is as though the recharger is breaking down.6.More than 40 percent of the time, by the time i get to my weekly recharge, the device program has been turned off by the system without me knowing why.The device has switched itself off without any input from me.7.The programmer does not save any program that i put into the system.This device automatically clears every input when you view another program setting.It has no memory at all.8.The programmer (phone) seems to have a life of its own.It is very slow to wake up, it won't recognize the recharger, can't communicate with it, it has equal difficulty 'speaking' to the communicator.9.On one occasion in (b)(6) 2022, when i finally managed my recharge (it took 1 hour 45 minutes) ¿ it said that it was battery was "fully charged" at 90% and would not go to 100% charge.I have only had the neurostimulator in my system since (b)(6) 2021.To lose 10% efficacy in 9 months will give this device a maximum lifespan of 81 months which is far shorter than the lifespan promised by medtronic.Fda safety report id # (b)(4).

• Brand Name: INTERSTIM NEUROSTIMULATOR MODEL 97810
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 15470318
• MDR Text Key: 300603272
• Report Number: MW5112218
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2022

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: Lay User/Patient
• Device Model Number: 97810
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2022
• Patient Sequence Number: 1
• Treatment: VIIBRYD 40 MG, BELSOMRA 20 MG, QULIPTA.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White