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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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| Model Number 3058 |
| Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Inadequate or Insufficient Training (1643); Insufficient Information (3190)
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| Patient Problems
Wound Dehiscence (1154); Diarrhea (1811); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554); Constipation (3274)
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| Event Date 09/21/2018 |
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.The patient stated that their reason for calling was to know if the implant can go bad; they had not had any problems in the last 14 years with the implants.It was reported that since they put their current implant in things haven¿t been like they were before; this is the first time being incontinent and they expressed concern about their ¿internal system.¿ they have to urinate, but it¿s not giving them any time before they feel the urge to go, and they will urinate ¿like 3 seconds later.¿ it was noted that they can use the programmer (pp) to adjust the program and settings to feel stimulation.It was also reported that it ¿just feels like they have been riding a bike all day¿ because they are sore ¿in that area,¿ around the implant site.It was stated that they feel like there is pain down there where the implant is located.It was further stated that it hurt so bad that they took the patient to the er and hospital for 4 days.It was noted that the patient guessed it was the infection; the patient just got out of the hospital with a urinary infection.Troubleshooting of making therapy adjustments was offered but declined.It was recommended that they follow up with their healthcare provider to check the lead and battery.It was stated that they had told a healthcare provider about the issue and they ¿just gave them some cream to take home to help with the issues they were having.¿ no further patient complications are anticipated or expected as a result of this event.
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Manufacturer Narrative
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After review of the additional information, device code (b)(4) has been removed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a health care professional.When asked to clarify the patient¿s concern with their ¿internal system ,¿ it was clarified that there was no issue; the cause of the patient¿s concern was that the patient had a uti.It was noted that they had only had one uti, prior to or since the device, and it started on (b)(6) 2018.The cause of the uti was unknown, and as a result, the patient was given antibiotics.There were no device issues reported, and no further patient complications are anticipated or expected as a result of this event.
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Event Description
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Additional information was received from the patient: caller states first implant lasted 8 years, and the second implant lasted 6 years.Patient states since he had his 3rd ins replacement he it has been giving him fits, which was clarified that the ins is not working like it did before because he is getting no relief of symptoms.Patient then later said he was getting some relief, but the ins was never programmed, and no one ever told him what the 4 programs mean.Patient states a week after the ins was implanted he had an infection (previously reported) and woke up in the hotel in a pool of blood and he could not control his bladder; patient went back to the hospital.Patient states if he turns the stimulation up too high he gets pains in his groin and back, and so he turns the stimulation down and the pain goes away but then he has incontinence.The patient had some bowel accidents a couple of days ago.The patient was advised to follow up with their doctor regarding their medical symptoms.The caller was very frustrated with the experience of the 3rd ins, became escalated and he was going to get a lawyer and hung up before further details could be gathered or troubleshooting done.No further patient complications are anticipated or expected as a result of this event.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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Event Description
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Additional information was received from a consumer.It was reported that since implant, they seem to have trouble with the device.Previously reported information was clarified; on the day of surgery, when they went back to their hotel, they woke up in a pool of blood because the incision opened up.They went back to the er and the doctor who was in surgery with their managing healthcare provider stitched it back up.The patient also reported that since this device was implanted, they feel electrical shock; this is the pain they feel, described as an electrical shock.The patient was still experiencing pain in their groin, noting that it first occurred about a year ago.When they experienced the groin pain the day before, they turned it down to 5 or 6, and that seemed to subside it.Later that night they were getting pain in the end of their penis, so they turned it down again today to 3 or 4.It was stated that program 2 ¿seems to get diarrhea and controls more of bowel movement than anything,¿ program 3 ¿gets constipation,¿ program 4 ¿seems like it gets pain and diarrhea.¿ program 1 was usually best, but they get groin pain, and recently they ¿have to go right now.¿ it was also reported that they get back pain and back aches in the area of the implant, and it had gotten a lot worse in the last couple years.It was noted that they took tylenol and aleve.The patient had a hospital visit, they went to the er 6 months, to almost a year ago, because they had no control of the bladder and bowel and had diarrhea.It was stated that the device ¿just seems like it¿s working what-so-ever¿ for them; they were having symptoms like when the second device ¿went out on them.¿ the patient had not had any falls or accidents and had told the healthcare provider about the problems they were having the last time they were there, about a year ago.The patient because upset so no troubleshooting was able to be performed.No further patient complications are anticipated or expected as a result of this event.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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