|
MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
| Model Number 8637-40 |
| Device Problems
Device Operates Differently Than Expected (2913); Temperature Problem (3022)
|
| Patient Problems
Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
|
| Event Date 09/08/2016 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Section d references the main component of the device system; the other relevant components include: product id 8780 lot# serial# (b)(4) implanted: explanted: product type catheter h6: patient code c50476 applies to only the pump.(b)(4).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.
|
| |
|
Event Description
|
|
Information was received from a consumer regarding a patient receiving clonidine with an unknown dose and concentration, bupivacaine with an unknown dose and concentration, and dilaudid with an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported patient was at the hospital due to device.It was noted patient felt that ever since the they got the catheter replaced the following issue have occurred.On (b)(6) 2016 it was stated patient had a catheter replaced and about 4 weeks after that the patient has been having episodes within 90 minutes of going from completely fine to developing a burning sensation right around the area of the pump.It was noted the burning sensation will spread around to patient's back and nail both legs even though one leg is really involved.Patient also gets crushing muscle spasms to the point where it gets very difficult to breathe.It was stated last night ((b)(6) 2017) patient went to the emergency room (er) stating they just got over a cold and got out of bed to send a couple of emails and reached for a pen and it triggered the episode.It was noted the er gave patient 15mg of intravenous (iv) valium to knock the spasms down to a tolerable level.It was noted these episode occurred infrequently and the last one before (b)(6) 20171 was on saturday (b)(6) 2017.Last night ((b)(6) 2017) it was stated patients blood pressure was up 200/135 and they ran all the statistics and tests on everything.Other than the patient's potassium level being low and needing to be corrected, everything was good.On (b)(6) 2017 (about 10 days ago) patient was in the intensive care unit (icu)after having the worst severe episode a week ago ((b)(6) 2017).It was stated patient's muscle start to go through lactic acidosis and gets worse and worse and the biggest concern was it was jamming up patient's liver and high blood pressure that occurred and was scared patient was going to stroke out and inside.It was stated patient can not keep going through these things.It was noted that patient's pump healthcare professional (hcp) wanted patient to get the stimulator placed and has no interest in the pump.It was stated that the pump has been a lifesaver for the patient and has gotten patient's life back together professionally since patient got the pump.It was noted patient had no idea what high frequency stimulator will or will not do; stating the old fashioned stimulator did not work for the patient.It was stated patient's hcp was on call last night and never returned patient's call and does not understand why hcp would not show more concern.Die.It was stated on (b)(6) 2017 patient was given an magnetic resonance imaging (mri) for ls spine and t spine and was in such pain that patient could not complete the mri because patient was in too much pain.It was noted patient was given medication and blood pressure continued to rise.It was stated patient normally was hypotensive 90/60 and has been since patient was a kid.It was stated that patient was told she had swelling around the catheter and from the ls spine mri pictures they were able to complete a nd wondered what would cause the catheter to swell.It was noted last wednesday ((b)(6) 2017 ) the weird part about this was patient stated when she called her internist, she reviewed she needs to figure out if patient was going to have a life and be alive, or sit in a fetal position until they figure the episodes out.It was stated patient had this conversation before going out to training day with her dogs, patient threw a ball and ran her dogs, and stated she is not running, but she is directing her dogs, blowing the whistle, and resting 45 minutes to an hour after each time as the internist instructed.It was stated but if patient just sits at her desk and leans forward for a pencil and it is painful and triggers the episodes.Patient feels the episodes are getting more and more and more often stating the patient is not getting more then 5 days between each incident and states within the last week patient had 3 of these and stated the prior incident was last saturday (b)(6) 2017 before last night ((b)(6) 2017).It was noted caller was to follow up with hcp.Caller stated a neurologist and a manufacturer person were going to evaluate patient today ((b)(6) 2017) with a full catheter study patient thought.Patient stated when twists lower trunk a little bit the abdomen muscles tighten up and then it creates the episodes patient has.It was stated patient's pump medication has not changed and has been the same for years.It was stated patient has not had any oral or supplement medication changes either.It was noted patient has not had any traumas or falls either.It was stated patient has had every muscle spasm known to man and has never had any crushing spasms like this ever that take her breath away.It was reviewed questions patient had about the pump and catheter and adverse events and considerations.It was reviewed diagnostics to discuss with hcp.Patient had medical questions and it was reviewed patient needed to have them addressed by/with hcp.Patient was redirected to hcp for next steps.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Event Description
|
|
Additional information received on 2017-feb-16 from a healthcare professional (hcp) reported having nothing further to report.Patient was discharged from the hospital and hcp has not seen the patient since then.It was stated patient had a contrast enhanced thoracic spine magnetic resonance imaging (mri) which was reported as normal.Otherwise, no additional evaluation since the initial report.It was noted that the episodes of burning sensation, crushing muscle spasms, and pain have not been resolved.It was noted it was still unclear what is happening.
|
| |
|
Manufacturer Narrative
|
|
Other components include: product id 8780 lot# serial# (b)(4) implanted: product type catheter (b)(4).Additional review determined that the previously reported information pertaining to manufacturer's report # 3004209178-2017-08753 [pump malfunctioning] was previously reported.Additional information regarding that event will be reported under this manufacturing number 3004209178-2017-03982 [episodes, hosp, sxs, mri].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.
|
| |
|
Event Description
|
|
Information was received from a healthcare provider (hcp) regarding a patient who was receiving clonidine, bupivicaine, and dilaudid at unknown concentrations and dosages via an implantable pump.On 2017-mar-29, it was reported that the patient's pump has been malfunctioning.According to the hcp, the pump malfunctioning began possibly in (b)(6) 2016, but the hcp wasn't positive.No symptoms were reported.No further complications were reported.Information was received from a healthcare provider (hcp) regarding a patient who was receiving clonidine, bupivicaine, and dilaudid at unknown concentrations and dosages via an implantable pump.On (b)(6) 2017, it was reported that the patient presented at the hospital with spasms and pain.No alarms were reported and the pump site did not appear infected.No further complications were reported.Additional information was received from the patient's healthcare provider on 2017-apr-25.It was reported that the patient had experienced several episodes since (b)(6) 2016, which were clarified as intermittent bouts of apparent drug withdrawal lasting hours to days and resulting in several hospitalizations.Pump interrogation and emptying and refilling the pump multiple times have been performed.No motor stalls were noted on the logs and no volume discrepancies were reported during refills.The catheter was aspirated without difficulty for csf.A contrast study was not performed due to a likelihood of withdrawal afterwards and low yield of imaging of the patient's catheter in a patient their size.An mri of the spine at t1 with contrast showed no catheter tip mass.The hcp speculated that the issue may have been due to a positional occlusion of the catheter.The hcp also reported that the patient's catheter was replaced for similar symptoms in (b)(6) 2016.Clonidine concentration and dosage were reduced on (b)(6) 2017.It was also presumed that the patient's pain and spasms were due to clonidine withdrawal with several recurrences.The cause had not been definitively determined and the patient was in the hospital again.
|
| |
|
Manufacturer Narrative
|
|
The main component of the device system; the other relevant components include: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: product type catheter h6: device code (b)(6) no longer applies.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
Additional information received on 2017-jul-14 from the patient reported ¿about 6-8 weeks later in about (b)(6) 2017¿ she experienced a new leg issue.The change in therapy/symptoms was considered gradual.The patient then stated that in ¿about (b)(6) 2017¿ her blood pressure would get high.The patient stated for these events she had been to the hospital about 6 times.The patient stated the new leg issue started when she was out walking her dogs, and her legs ¿didn¿t feel quite right¿, so she went to her car to sit down.The patient stated both her legs felt a little bit like they were burning.The patient stated normally there was nothing wrong with the right leg.The patient stated she sat in her car for about 45 minutes, and in that time, she had muscle spasms in both her legs.The patient stated she stuck straight out, and she couldn¿t bend either leg and couldn¿t put her feet on the ground.The patient stated she felt like she was being crushed.The patient stated it really hurt and was unbearable pain.The patient stated she went to the er.The patient stated they treated her with an iv of dilaudid and kept her for about 5-6 hours to make sure there was nothing wrong with the right leg.The patient stated again ¿it hurt really bad¿.The patient stated she began to see a pattern.The patient stated, ¿i realized in the time frame from when i started having symptoms, if i looked back about half an hour, i started seeing a pattern¿.The patient stated, ¿the issue is positional¿.When she would lean over and twist left, that was when the spasms would hit.The patient stated it would take 1-2 weeks for her to feel better with the legs.The patient stated her blood pressure would get ¿outrageously high¿ when the spasms hit.The patient stated normally her blood pressure was 90/60.When she had the spasms, the blood pressure would to up to 216/130.When she had the spasms, she had to burn through potassium because when she was in the hospital er they gave her a ¿truck load¿ of potassium.The patient stated the clonidine dose and concentration were ¿set higher than recommended¿.The patient stated a doctor from the er had suggested replacing the pump.The patient stated the pump had worked flawlessly and did not have any complaint about the therapy.The patient did not want the pump traded out for a stimulation device.The patient asked if what was happening to her could be the result of the medication.There was no out-of-box failure reported.There was no medical or therapy problem associated with small parts.There was no troubleshooting done on the call.
|
| |
|
Manufacturer Narrative
|
|
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Search Alerts/Recalls
|
|
|
