MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Fatigue (1849); Micturition Urgency (1871); Incontinence (1928); Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Urinary Frequency (2275); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3889-28, lot# va1dxk6, implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient stumbled and fell on their right knee.Patient stated that it jolted them and stimmed them.It shook them up.Patient stated after the fall, they started having leakage problems and getting up to go to the bathroom like they were 3-4 times a night.Patient fell again a half a foot at the gym and it stimmed them again.Patient told the doctor that they didn't think the therapy was working right but they said it was ok.Patient told them in (b)(6).Patient also reported of having a lot of sciatica so on (b)(6) 2017 so they turned stim off.It didn't help with the sciatica at all.Patient ended up having acupuncture therapy which helped the bladder but sciatica had not gone away.Patient did meet with the representative on (b)(6) 2017 and they found 2 leads were broken or cut.Patient stated that the rep fixed it but they had not turned stim on since because the acupuncture seems to be helping.Patient inquired if it was an issue to have wires loose in her body.Patient felt like not having energy and was exhausted.Patient was advised to consult with doctor for more information.There were no other malfunction or complication were reported.Patient was implanted for patient was implanted for urinary dysfunctional/sacral nerve stimulation and gastrointestinal/ pelvic floor.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id (b)(4) lot# va1dxk6 implanted: (b)(4) 2017 explanted: (b)(4) 2017 product type lead (b)(4), ubd (b)(4) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional: the device was working unipolar (case to lead with increased impedance).The cause of the impedance issue was due to new onset of recurrent falls: the patient was to be evaluated for a new device to treat their parkinson's disease.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3889-28, lot#: va1dxk6, implanted: 2017 (b)(6), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the patient had lower back pain.Patient was instructed to keep interstim off for 1 week and then turn back on.They demonstrated ability to turn device on and off successfully.For overactive bladder patient was to continue kegel's, urge strategies and bladder-sensitive diet.Interstim was on program 3 at 1.35v.Patient was educated on they should not feel stimulation on a constant basis.Impedances were found on all 4 leads (electrodes) >4000 ohms.Pulse width changed to 300 for all leads.Programs changed from bipolar to unipolar (case to lead).Patient also had mixed urinary incontinence, incomplete bladder emptying, and fecal incontinence.Reviewed with patient today their prior symptoms of urinary incontinence, nocturia, pads at their prior appointments, voiding frequency, number of urgency and frequency events as patient had limited recall of the change in their symptoms before interstim, after pne, after interstim placement, and after fall and damage to device.Patient would continue with interstim off as they were doing well at the moment.Reviewed that they may continue to have residual symptoms reduct ion, but that would likely be temporary.When symptoms return they could consider turning therapy back on.Also reviewed given that damage to device post fall battery life would be reduced (can only use programs that were case to lead) and had limited programs.May need to replace lead in future.Before removing lead, recommend patient continue with device off for a period of time as symptoms were likely to return and that would give ability to resume neuromodulation.Patient was planning trial of acupuncture.If symptoms returned they would decide based on costs whether to continue acupuncture versus undergoing trial of interstim.Device reprogrammed in the event that patient would like to turn device back on.Patient instructed to call hcp if they would like to turn back on.There were no further complications reported.

Manufacturer Narrative

The other applicable components are: product id: 3889-28, lot# va1dxk6, implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer (con).It was reported that the device was turned off the first week in (b)(6).They were experiencing extreme nerve pain in their right buttock and leg.They went to acupuncture in from (b)(6) to (b)(6) 2017, which was controlling their bladder and bowel problems, until they went for physical therapy for sciatic nerve pain.They thought the muscle spasms, nerve pain, and sciatica were a result of the implant.It was noted that the wetting/leaking stopped 1.5 weeks after physical therapy, but the pain was still present.They were also experiencing energy loss, balance issues, and trouble with penmanship, which had never been a problem.It was later reported that the pain subsided, contradicting the previous report.They also reported having staggered walking.

Manufacturer Narrative

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

Event Description

Additional information received from the patient.They are currently receiving physical therapy treatments for their sciatica.Upon their first visit, they provided medical procedures/related warnings and effects with respect to their implantable neurostimulator (ins), but on their first visit, there was "nothing in their file." after being reassured by the physical therapist, the patient received heat ultrasound with their ins; low settings was used.On (b)(6)2017, the patient saw another physical therapist who was going to perform modulating massage on the patient.The patient asked the physical therapist to call the manufacturing company to determine if it wasn't going to harm their ins, but the physical therapist told the patient to call.The patient was uncomfortable, but let the physical therapist proceed because their expertise is "modulating massage;" the patient was in pain friday through monday.The patient asked the physical therapist if they knew where the leads were, but they said "no" and didn't call to find out.The patient informed the physical therapist that a manufacturer representative (rep) found two "cut leads" on their ins on their (b)(6)2017 visit and had them repaired.Furthermore on (b)(6)2017, patient told their physical therapist about the pain; the physical therapist had the patient do floor exercises.Patient hoped there wasn't damage to their leads so they called into the manufacturing company.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received on from patient who is going to have their implantable neurostimulator (ins) removed on (b)(6)2018 and their hcp is recommending an ekg before surgery.The patient's ins has been off since september 2017.When asked, the patient's ins is going to be removed because they've experienced a lot of leg pain on their right leg and "sitz" bone and it is frequent and very painful; they've tried going to acupuncture and physical therapy and nothing helped.The patient thinks this pain is related to their ins and also reported sciatic pain.They then said their ins was not helping with their bladder/bowels and they were getting up to go to the bathroom 3-4 times a night.They fell down about 3 weeks after the ins was implanted and then noticed therapy was not working well with respect to their bladder/bowel symptoms.They noted that they fell on their knee on the opposite side of their ins, and when they fell, "it jolted me;" it felt like electricity.They didn't mention this to their hcp right away until about a month later; the hcp didn't think their ins was "messed up." when asked about notifying the rep, the patient said they think the hcp called the rep in august 2017 because they were concerned the ins was not working.Additional information received from a manufacturer representative (rep); they were not made aware of the "not working" issue.The rep said they needed to be programmed, and to their knowledge, it was working fine.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3889-28, lot# va1dxk6, implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead, ubd: 2021-01-16, (b)(4).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 the patient went for sciatica treatment, the therapist used heat ultrasound and modulating massage, and the therapist refused to call the hcp or manufacturer to see if the heat/massage were compatible with the implant.Patient had hcp appointment on (b)(6) 2018, and implant removal was scheduled for (b)(6) 2018 as it had been causing sciatica, lots of nerve pain since (b)(6) 2017, and physical therapy and acupuncture did not alleviate the pain.The patient also reported the cause of the ins not working was that they fell down 3 weeks after implant.Patient started losing balance one month later to present time.Patient has experience a lot of pain in the right leg with no relief from pt or acupuncture and implant was removed (b)(6) 2018.The patient now has lower back pain/did not have back problems.The patient's right leg pain has subsided since removal.Patient is still experiencing loss of balance., and never had problems before experiencing the symptoms of parkinson's disease.The patient plans to get a neurologist,and believes the implant caused this.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare professional (hcp).It was reported that the device does not cause parkinson's disease and the parkinson's symptoms and disease was not related to the device or therapy.There were no further complications or anticipations reported with this event.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 7152746
• MDR Text Key: 96129110
• Report Number: 3004209178-2017-26765
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2018

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: 09/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/02/2018; 01/16/2018; 01/12/2018; 02/06/2018; 03/07/2018; 04/16/2018; 05/15/2018
• Supplement Dates FDA Received: 01/09/2018; 01/22/2018; 02/09/2018; 03/06/2018; 03/15/2018; 04/20/2018; 05/22/2018
• Date Device Manufactured: 04/05/2017
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 63