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

Model Number 3058

Device Problems Energy Output To Patient Tissue Incorrect (1209); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Therapeutic Response, Decreased (2271); Anxiety (2328)

Event Date 11/02/2014

Event Type  Injury  

Event Description

It was reported that the clinician programmer data from the health care provider (hcp) said the patient¿s device was off, but the patient was almost certain that their stimulation was on.The patient wanted to know why there would be a discrepancy.The data from the clinician programmer was not matching up with what the patient programmer showed and the patient noticed this issue 2 days ago when they went for their hcp appointment.The physician¿s assistance (pa) at the hcp¿s office told the patient that their machine never lies and the clinician programmer told them the device had been off from (b)(6) 2014.The patient was almost certain that could not be true because they felt stimulation, made adjustments, and was 90 percent certain that they saw the lightning bolt on the screen.Since the pa¿s clinician programmer showed that it was off, they didn¿t want to do reprogramming because they hadn¿t really tried the programs out.The patient went to a physical therapy session 4 days ago and they turned it off and back on.The patient didn¿t even know how to turn stimulation off and needed instructions to do it, so they didn¿t think they would have been able to do that.The hcp told the patient that they changed programs at that time and the patient reported that they didn¿t.The patient specifically remembered going in for a haircut sometime in (b)(6) and they had just changed programs.When they sat down they felt it too strong so they switched back to a different program.The patient felt stimulation in their vagina and then felt a woosh go down their leg and in their pelvic region and it scared them.Had the stimulation been off, the patient would have been a mess and they weren¿t.The pa called the manufacturer representative to see what their input would be on the issue and they said they didn¿t know.The manufacturer representative instructed them to try changing the patient programmer batteries.There was another time where there was a discrepancy with what the clinician programmer said and what the patient thought they were on.The pa said the patient was on program 2, but the patient thought they were on program 3.This was sometime in the end of (b)(6) and this discrepancy may have been the patient¿s mistake, but they were not sure.The patient just remembered thinking that didn¿t sound right.The patient did a diary and their hcp still didn¿t have an answer.The patient had a loss of therapeutic effect around the beginning of (b)(6) and they were losing a little bit of control.It was working better in the beginning, but the patient began to lose control and had some leaking and that was why they went in to get the programs changed.The patient was feeling stimulation, but it wasn¿t as good as it had been.That was what confused the patient because they felt stimulation on so they really didn¿t think that it was off.The patient was not noticing better control since their hcp¿s appointment, now that they knew it was on.The patient still felt like they could be getting better control.The patient¿s next appointment would be on (b)(6) 2015, but they may reschedule it so it was sooner.It was further reported that the patient had been using the stimulation therapy in (b)(6) and was getting therapy control.Only several times they questioned the efficacy.The therapy had initially been working well and after that appointment the patient had been taking notes on when they turned stimulation on, off, up, and down.The patient no longer felt like they had an implant anymore because it wasn¿t providing therapy.The patient requested a new patient programme r based on them not trusting that their programmer was completing the requested actions.No outcome or interventions were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 3037, serial # (b)(4), product type programmer, patient; product id 3093-28, lot # va0kf19, implanted: (b)(6) 2014, product type lead; product id 3037, serial # (b)(4), product type programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that there was a 50 percent or greater symptom reduction.The cause of the event was determined, it was unknown if it was device related, and reprogramming was needed.The device was off from 2014 (b)(6) to 2014 (b)(6) and the patient reported changing programs and feeling the sensation during this period on 2014 (b)(6).The troubleshooting, interventions, or other actions taken to resolve the event was that they discussed the case with the manufacturer representative who instructed them to change the batteries and they would talk with the tech.They saw the patient on 2014 (b)(6) and according to the health care provider's (hcp's device the patient was on program 4, but the patient's programmer and log showed differently.The patient did experience a sudden loss of therapeutic effect and a sudden loss of stimulation as the device was off.The patient recovered with permanent impairment.The patient still had concerns regarding their device or therapy, but was working with their hcp or manufacturer representative.The patient had appointments on 2014 (b)(6) and 2015 (b)(6).Analysis resoldered the antenna jack of the patient programmer for preventive maintenance.

• 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 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: 4375832
• MDR Text Key: 5260558
• Report Number: 3004209178-2014-24745
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• 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
• Report Date: 12/05/2014

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: 12/14/2015
• 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: 12/24/2014
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2015
• Date Device Manufactured: 06/16/2014
• 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: 00056 YR