|
MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
| Model Number 8637-40 |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
|
| Patient Problems
Apnea (1720); Bradycardia (1751); Cyanosis (1798); Encephalopathy (1833); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Muscle Weakness (1967); Seizures (2063); Swelling (2091); Coma (2417); Loss of consciousness (2418); Low Oxygen Saturation (2477); Respiratory Acidosis (2482); Decreased Respiratory Rate (2485); Cognitive Changes (2551); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
| Event Date 06/09/2020 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported that the patient had recovered ¿wonderfully well¿.The hcp had a conversation with the patient¿s parents and saw the patient again.The patient functioned ¿almost as usual again¿.
|
| |
|
Manufacturer Narrative
|
|
If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal compounded baclofen via an implantable pump.The dose and concentration were unknown.It was reported that a refill was performed on (b)(6) 2020 at approximately 3pm.2 hours (more or less) after the refill, the patient¿s parents noticed that the patient ¿responded less consciously¿.An ambulance came, and the ¿ambulance brothers were also unable to reach the patient¿.The ambulance took the patient to the hospital.The patient was hospitalized, and a pocket fill was detected.The baclofen pocket fill caused the patient to have an epileptic seizure and resulted in the patient currently being in a vegetative state (brain dead).Neurosurgery immediately ¿sucked the pocket and injected something to dilute medication¿.Mannitol was given against brain swelling.On (b)(6) 2020, the patient had woken up and was approachable again.The situation looked positive.Nothing could be said yet about possible neurological injuries.The patient¿s status was unknown.It was unknown if the issue was resolved.It was further reported that the patient had recovered well but was still in the hospital.No further diagnostics/troubleshooting were performed.Surgical intervention did not occur and was not planned.The internal inspectorate (of the hospital) was also going to investigate this case; this report would not be shared with the device manufacturer.Information regarding the patient¿s age, weight, medical history, and other medications was unavailable.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Manufacturer Narrative
|
|
Section a, section b, section h: updated to reflect the information received in the attached literature article citation: muntinga l, klijn aj, noordergraaf gj.A severe baclofen intoxication mimicking post-hypoxic encephalopathy: wait and see! j emerg med.2022;62(3):e44-e46.10.1016/j.Jemermed.2021.11.007 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.
|
| |
|
Event Description
|
|
Citation: muntinga l, klijn aj, noordergraaf gj.A severe baclofen intoxication mimicking post-hypoxic encephalopathy: wait and see! j emerg med.2022;62(3):e44-e46.10.1016/j.Jemermed.2021.11.007 summary/abstract: abstract¿background: a severe baclofen intoxication is a potentially life-threatening condition.It is associated with coma and can cause brainstem reflexes to disappear, simulating a brain death-like condition.When given intensive supportive care and time, patients can recover without residual neurological damage.Case report: we present a case of a patient with known spastic cerebral palsy who was found unresponsive with no signs of breathing.He was brought to the emergency department, intubated, put on the ventilator, and hemodynamically stabilized.Brainstem reflexes were absent and he appeared brain dead.During the secondary survey, an intrathecal baclofen pump was found at his left lower abdomen, with a swelling next to it.A baclofen intoxication was suspected.He was admitted to the intensive care unit, and after 72 h of supportive care complete neurological recovery was achieved.Why should an emergency physician be aware of this?: systemic baclofen intoxication can simulate a brain death-like condition.There is no reliable correlation between baclofen serum levels and central nervous system depression in case of an intoxication.It is important for emergency physicians to recognize a baclofen intoxication as a possible cause of coma and absent brainstem reflexes.Recuperation is spontaneous and can follow within days without residual damage.Because these patients may be brought in after a period of apnea or cardiopulmonary resuscitation, focus may be on post-hypoxic encephalopathy considerations instead of a possible baclofen intoxication.Reported events: a 21-year-old man was brought to the emergency department (ed) with an altered level of consciousness and absence of breathing.Prior to his arrival at the ed, an epileptic seizure was suspected by his mother.She had given him nasal midazolam, but when he remained unconscious and became cyanotic, emergency medical services were alerted.When the paramedics arrived, he was deeply hypoxemic.The initial oxygen saturation was undetectable and there was no spontaneous respiration.He was manually ventilated with a laryngeal mask and transferred to the ed.Upon admission, the airway was protected by immediate intubation and mechanical ventilation.On initial examination, his oxygen saturation was 88%, blood pressure was 80/35 mm hg, and heart rate was regular at 40 beats/min.Body temperature was 36.8°c and glucose levels were normal.He had a respiratory acidosis with an arterial ph of 7.28, po2 54 mm hg, and pco2 55 mm hg.His electrocardiogram showed sinus bradycardia, with a rate of 54 beats/min.A quick neurological examination prior to intubation showed a glasgow coma scale score of 3.Spontaneous movement was absent and there was diffuse hypotonia.His pupils were unresponsive to light and there was bilateral mydriasis.Corneal, oculocephalic, or gag reflexes were absent.The secondary survey revealed a subcutaneous superficial bulge in his left lower abdomen.Due to asphyxia at birth, the patient suffered from spastic cerebral palsy and epilepsy.For the last decade his spasms were treated with intrathecal baclofen administration.The current daily dosage was 850 ¿g/24 h.Earlier that day, the baclofen pump had been refilled.According to the patient¿s mother the physician administering the baclofen had unusual difficulties injecting the baclofen into the reservoir.In the ed, 30 ml of fluid was aspirated from the subcutaneous pocket next to the baclofen pump.The actual pump reservoir held 38.9ml and the baclofen concentration was 3 mg/ml.A baclofen intoxication was suspected.Mannitol 0.5 g/kg was administered to treat potentially increased intracranial pressure due to post-anoxic cerebral edema after his respiratory arrest.A computed tomography scan didn¿t show a clear cause for his loss of consciousness.The patient was admitted to the intensive care unit (icu), where he remained stable while on mechanical ventilation.The patient¿s parents were informed that their son might never wake up again and potential organ donation was mentioned.On the second day in the icu his neurological condition remained unchanged.An electroencephalogram showed severe encephalopathy, but could not disc riminate between hypoxic brain injury and a nonconvulsive status epilepticus.Because further investigation didn¿t result in an evident explanation for his unconsciousness, persisting baclofen intoxication was strongly suspected.In the next few days his neurologi cal condition improved and his brainstem reflexes returned to normal.After 72 h in the icu, the patient was extubated.His family confirmed that his mental status was back at his baseline.Once the overdose symptoms were resolved, baclofen was reinstated to prevent serious baclofen withdrawal symptoms.He was discharged to the neurological ward in good clinical condition.
|
| |
|
Search Alerts/Recalls
|
|
|
