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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
Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
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| Patient Problems
Incontinence (1928); Unspecified Infection (1930); Muscular Rigidity (1968); Device Overstimulation of Tissue (1991); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/01/2021 |
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Event Type
Injury
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient called to inquire about compatibility for multiple tests.Patient services reviewed this information and the patient reported that in late (b)(6) (the patient believed it was on (b)(6) 2022) or (b)(6), the patient was at the grocery store and they backed up into a person's shopping cart.The patient stated they "swore" the impact was right at their implant site and at the moment of the impact, they said "ouch." the patient stated their right arm also bumped against the top of the cart but they stated the implant seemed to be ok even though they were still concerned about the incident.The patient also stated they went to a new pelvic therapist on (b)(6) 2022 and that's where the therapist "messed things up." the patient stated the therapist "kind of touched on the area where the left side nerve was," and since then, the patient stated they were noticing now that they've been going "number 2 more," peeing more frequently (they thought they went four times today already,) and their bladder wasn't emptying as good.The patient confirmed that urinary retention was one of their underlying urinary dysfunctions for which they were implanted.The patient confirmed they were experiencing "a return of symptoms return " since that appointment with the pelvic therapist.The patient reported they decided never to go back to that pelvic therapist again and went back to their original pelvic therapist after that instance and that they have been working with the therapist to try to get back to better relief of their symptoms.Patient services reviewed they could assist the patient in taking a look at their settings and potentially making a change to their settings however stressed to the patient that if they were concerned that either the 'shopping cart incident' or the pelvic therapist adjustment had caused an issue with the implanted system that they should review their symptom concern with their managing health care provider (hcp) and have the hcp check the implanted system.The patient declined making a change given they wanted to talk with their hcp about this issue and also because the pelvic therapist had just done some "internal work," on them today ((b)(6) 2022) so they wanted to see if that helped prior to making any additional changes.The patient reported that they had been on the same program and stimulation setting for a long time and they were told that the program they were initially placed on should work the best for them.The patient mentioned that they recently switched hcps and that their previous hcp had told them to never use a dilator however when the patient worked with their pelvic therapist, the pelvic therapist told the patient a dilator shouldn't cause any issue so the patient tried a dilator back in (b)(6) 2021 and that "made everything out of wack." the patient stated they used it once and stated they would never use it again because they couldn't pee and the therapy no longer seemed to work 100% like it had before they used the dilator.The patient stated it had started to work really well again in march and that was when the 'shopping cart incident' happened and when they went to the other pelvic therapist.Patient services documented the patient's report as accurately as possible and redirected the patient back to their managing hcp to discuss symptom concerns and to check the implant.The patient was going to reach out to their hcp.
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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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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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient called to inquire about compatibility for multiple tests.Patient services reviewed this information and the patient reported that in late (b)(6) (the patient believed it was on (b)(6) 2022) or early (b)(6), the patient was at the grocery store and they backed up into a person's shopping cart.The patient stated they "swore" the impact was right at their implant site and at the moment of the impact, they said "ouch." the patient stated their right arm also bumped against the top of the cart but they stated the implant seemed to be ok even though they were still concerned about the incident.The patient also stated they went to a new pelvic therapist on (b)(6) 2022 and that's where the therapist "messed things up." the patient stated the therapist "kind of touched on the area where the left side nerve was," and since then, the patient stated they were noticing now that they've been going "number 2 more," peeing more frequently (they thought they went four times today already,) and their bladder wasn't emptying as good.The patient confirmed that urinary retention was one of their underlying urinary dysfunctions for which they were implanted.The patient confirmed they were experiencing "a return of symptoms return " since that appointment with the pelvic therapist.The patient reported they decided never to go back to that pelvic therapist again and went back to their original pelvic therapist after that instance and that they have been working with the therapist to try to get back to better relief of their symptoms.Patient services reviewed they could assist the patient in taking a look at their settings and potentially making a change to their settings however stressed to the patient that if they were concerned that either the 'shopping cart incident' or the pelvic therapist adjustment had caused an issue with the implanted system that they should review their symptom concern with their managing health care provider (hcp) and have the hcp check the implanted system.The patient declined making a change given they wanted to talk with their hcp about this issue and also because the pelvic therapist had just done some "internal work," on them today ((b)(6) 2022) so they wanted to see if that helped prior to making any additional changes.The patient reported that they had been on the same program and stimulation setting for a long time and they were told that the program they were initially placed on should work the best for them.The patient mentioned that they recently switched hcps and that their previous hcp had told them to never use a dilator however when the patient worked with their pelvic therapist, the pelvic therapist told the patient a dilator shouldn't cause any issue so the patient tried a dilator back in (b)(6) of 2021 and that "made everything out of wack." the patient stated they used it once and stated they would never use it again because they couldn't pee and the therapy no longer seemed to work 100% like it had before they used the dilator.The patient stated it had started to work really well again in march and that was when the 'shopping cart incident' happened and when they went to the other pelvic therapist.Patient services documented the patient's report as accurately as possible and redirected the patient back to their managing hcp to discuss symptom concerns and to check the implant.The patient was going to reach out to their hcp.
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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 received from patient.They reported they have contacted their hcp.Patent stated the use of the dialator was urged by their pelvic therapist.They clarified that everything out of whack and everything messed up was that they needed to empty bladder but the stimulation wouldn't go where it should for about an hour then able to go.The device worked ok after about an hour.The level in program 1 is not as noticeable when switching to it.(used.40).The steps for resolution is pelvic therapy.Patient did experience retention prior to implant and some catetherization is patient's standard of care.Retention symptoms have not worsened.
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Event Description
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Additional information was received from the patient.The patient called back to inquire about managing health care providers (hcps).The patient reported initially that since they had their 2nd cystoscopy on (b)(6) 2022, their urinary retention symptoms returned.The patient stated they were at a.4 v on program 1 prior to the cystoscopy and that it helped moved their bladder quicker, but that after the cystoscopy, they had to decrease the stimulation to.3v because it made their pelvic region "really stiff"/they were retaining urine and thus the therapy relief wasn't as good and the tightness was painful.The patient stated they had urges from 10 am to 6 pm and they'd hardly get anything out.The patient stated they were treated with antibiotics and they were also given muscle relaxers but that did not help and stated they may be put on long term antibiotics and that they currently had a urinary tract infection.The patient reiterated they were in pelvic therapy and that they'd just had their second session and they were told they could lower the stimulation because of the stiffness but the patient was concerned about their nerves.The patient stated that even before the cystoscopy, they'd had a reprogramming session on (b)(6) 2022 with a manufacturer representative (rep) and the rep didn't seem to know what programs a, b, c or d were.The patient stated they'd been on program 1 for a long time and then they were put on program 2 the patient stated they wondered "did i get some nerve damage here?" because on the one program it was going to the front part of the urethra and then it would start going towards the back on the new program and when they sat down it was spasming.Patient services reviewed programs and device description/function with the patient.The patient stated that the rep noticed an electrode was "'out' or 'impeded'" at that time.The patient stated at least then, their symptoms weren't as bad then, there wasn't tightness then, that they'd only been having retention during the day but they were going mostly at night (as compared to the tightness/symptom return they've been having since their 2nd cystoscopy.) the patient stated they hadn't had the system checked since the cystoscopy.Patient services reviewed it would be best to follow up with a managing hcp to check the implanted system and to address their symptom concerns.Patient services also sent the patient physician listings at the patient's request.The patient stated they were going to reach out to a hcp.The patient also mentioned additional medical information: that they had a bone marrow transplant on (b)(6) 2022.
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Manufacturer Narrative
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Continuation of d10: product id 978b128, lot# va2884d, product type lead.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 the patient.The patient called back and reported they had custom programs put in in february and had been on program d so they went to hcps office last tuesday where they met a manufacturer representative (rep) named (b)(6).The patient stated hannah "changed it and added two more things to their program d.2 more boxes to make it stimulate on the bottom." the patient stated it was just too strong for them however because they could feel it through their whole perineum and could even sometimes feel it in their "inner nerve." the patient stated they had been going to the bathroom every hour, that it was like they were at "300" and the night before last they would go quite a bit and went at least four times.The patient stated they brought the stimulation down last night before they went to bed but then it wasn't enough for their symptoms.The patient stated hcp from the mayo clinic called them last night and told them "this could happen." the patient stated they'd been trying to reach (b)(6) but hadn't been able to get a hold of them and wanted assistance in getting it to another program.Patient services walked the patient through connecting to their settings.The therapy was on.The patient chose to program c which they stated they had never been on before but they didn't understand why when they went to program c it was at.1 v already.Patient services asked the patient if the rep had potentially had the patient at that level previously and the patient stated "no." the patient increased the stimulation to.2 v but they felt an uncomfortable clicking in their bike-seat region and it was uncomfortable so they backed the stimulation down to.1 v again.The patient stated they'd monitor their symptoms now that change had been made.The role of the rep was again reviewed with the patient and patient services redirected the patient to follow up with their hcp if they still did not see relief from the change.
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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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