MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Unspecified Infection (1930); Muscle Weakness (1967); Muscular Rigidity (1968); Seroma (2069); Diaphoresis (2452); Shaking/Tremors (2515); Sleep Dysfunction (2517); Swelling/ Edema (4577)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

Citation: gburek-augustat, j., krause,m., bernhard, m., sorge, i., grafe, d., siekmeyer, m., nestler, u., merkenschlager, a.Unusual mechanical failures of intrathecal baclofen pump systems: symptoms, signs, and troubleshooting.Child's nervous system.2021.The reported age reflects the average age of the patients reported in the literature article.The reported sex reflects that of the majority of the patients reported in the literature article.Please note that this date is based off the date of publication as the actual event date was not provided.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant medical products: product id: neu_ascenda_cath, serial#: unknown, product type: catheter.Product id: 8637, serial#: unknown, product type: pump.Product id: neu_ascenda_cath, serial# unknown, product type: catheter.Product id: 8637, serial#: unknown, product type: pump.Product id: neu_ascenda_cath, serial#: unknown, product type: catheter.Product id: 8637, serial#: unknown, product type: pump.Product id: 8637, serial#: unknown, product type: pump.Product id: neu_ascenda_cath, serial# :unknown, product type: catheter.Product id: 8637, serial#: unknown, product type: pump.Product id: neu_ascenda_cath, serial#: unknown, product type: catheter.Product id: 8637, serial#: unknown, product type: pump.Product id: neu_ascenda_cath, serial#: unknown, product type: catheter.Product id: 8637, serial#: unknown, product type: pump.Product id: 8637, serial#: unknown, product type: pump.Product id: neu_ascenda_cath, serial#: unknown, product type: catheter.Other relevant device(s) are: product id: neu_ascenda_cath, serial/lot #: unknown, ubd:, udi#:.Product id: 8637, serial/lot #: unknown, ubd:, udi#:.Product id: neu_ascenda_cath, serial/lot #: unknown, ubd:, udi#:.Product id: 8637, serial/lot #: unknown, ubd:, udi#:.Product id: neu_ascenda_cath, serial/lot #: unknown, ubd:, udi#:.Product id: 8637, serial/lot #: unknown, ubd:, udi#:.Product id: 8637, serial/lot #: unknown, ubd:, udi#:.Product id: neu_ascenda_cath, serial/lot #: unknown, ubd:, udi#:.Product id: 8637, serial/lot #: unknown, ubd:, udi#:.Product id: neu_ascenda_cath, serial/lot #: unknown, ubd:, udi#:.Product id: 8637, serial/lot #: unknown, ubd:, udi#:.Product id: neu_ascenda_cath, serial/lot #: unknown, ubd:, udi#:.Product id: 8637, serial/lot #: unknown, ubd:, udi#:.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: we here describe six unusual mechanical itb complications, occurring in most of the patients after a long and successful treatment period, which obscured some of the hints to diagnosis and treatment of the failure.We use synchromed ii pumps from medtronic with corresponding ascenda catheters.We applied a variable flow for patient case 6 and a fixed flow for all other patients.Reported events: event 1: at the age of (b)(6) years, the boy suffered from a traffic accident with considerable brain trauma.He developed a severe residual syndrome with spasticity gmfcs v and appallic syndrome.A (b)(6) years a baclofen pump was implanted with good effect on muscle tone.The pump was refilled regularly.5 years after pump implantation a pump alarm occurred and few hours later, he presented to the emergency room with high muscle tension, sweating, and trembling.Baclofen withdrawal was suspected.Creatine kinase was increased to 15.02 mckat/l.The suspected baclofen withdrawal symptoms were treated with oral baclofen, diazepam, continuous administration of analgesics and high volume infusion therapy.An x-ray was taken and was unremarkable.Contrast medium was applied and no contrast medium flow into the catheter system could be shown.A ct was performed and no leakage was demonstrated.Disconnection of the catheter was not detectable, so pump replacement was indicated.During intraoperative evaluation, a corroded and thus no longer functional pump was found.A new pump was implanted and the symptoms resolved.Event 2: a girl had fell victim to carbon monoxide poisoning at the age of (b)(6) years.As a result, she developed spasticity gmfcs v and an apallic syndrome.A baclofen pump was implanted 1 month after the accident, and intrathecal baclofen therapy showed good effect on muscle tension.Five years later the patient was presented with a soft, indolent abdomen.Spasticity had worsened in the previous weeks, so the baclofen dosage had been increased step by step.The swelling on the abdomen was punctured and serous fluid was collected.Thefluid showed a high protein content (total protein 8.4 g/l) and no inflammatory cells, so it was interpreted as leakage out of the catheter.Surgical revision was performed, and the connector from the catheter to the pump was found to be loose.Baclofen was leaking from the proximal and cerebrospinal fluid from the distal part.The pump at the end of battery lifetime and the connector were replaced.Subsequently, a lower baclofen dosage was required to obtain sufficient treatment effects.Event 3: at the age of (b)(6), the boy suffered from hypoxic brain damage and subsequent bilateral spasticity gmfcs v as result of a drowning accident.Four months later, a baclofen pump was implanted with good effect.During the longer course, the patient developed inactivity osteoporosis and experienced several bone fractures.With 12 years, treatment with bisphosphonates was therefore initiated.Overall, itb was carried out in the patient for 13 years without any problems.Shortly before the planned explantation of the pump because of low battery charge, the patient¿s spasticity worsened.A ct scan was performed under suspicion of catheter dysfunction which showed subdural contrast depots at two points and a subcutaneous catheter rupture.For that reason, both pump and catheter were explanted.Intraoperatively, it was recognized that the tissue around the pump was hardly movable, calcareous coating of the pump was noticed, and the entry point of the catheter into the spinal canal was found to be surrounded by chalky, strongly adherent tissue.The calcification was very unusual and was interpreted as an adverse side effect of the bisphosphonate therapy.Six days after replacement, wound dehiscence developed with purulent secretion.The patient suffered from fever and laboratory results showed leukocytosis and increased serum crp values.(b)(6) was identified in local wound specimen and blood culture.Antibiotic treatment with cefotaxime and clindamycin was started.The new pump and the entire catheter system had to be completely removed.The patient then developed pronounced withdrawal symptoms after the pump explantation: shakiness, sweating, agitation and increase in spasticity.He received high doses of oral baclofen, midazolam, clonidine and dronabinol to alleviate the withdrawal symptoms.The patient¿s condition slowly improved, and a new pump system was reimplanted several months later uneventfully.Event 4: following periportal varicella encephalitis associated with intracerebral hemorrhage, the newborn girl developed bilateral spastic cerebral palsy gmfcs v.At seven years itb (intrathecal baclofen) was started with an initially good response.The first complication occurred as soon as 1 month after pump implantation.An increase in spasticity and a higher frequency of crying periods were reported.By increasing the baclofen dose from 150 to 320 mcg/d, no improvement of the symptoms could be achieved.X-ray demonstrated a dislocation of the intrathecal catheter.The catheter was rolled up at the level of l3 and could be repositioned into the intrathecal space neurosurgically.A long-term complication occurred 4 years later when spasticity and restlessness increased again.An x-ray was inconspicuous.Two months later, a discrepancy during pump filling was found.While 2.1 ml were supposed to be in the pump reservoir, 11 ml could be extracted.This showed a reduced extrusion of baclofen without programmed lowering of the flow rate.The catheter access port was punctured.Neither cerebrospinal fluid could be aspirated nor contrast agent injected.Surgical pump explantation revealed a coiled spinal catheter which had led to a functional closure of the catheter.Retrospectively, the detection of the once more subcutaneously twisted catheter on the x-ray images remains challenging.Event 5: the patient presented with an addison¿s crisis and severe hypoglycemia as initial manifestation of x-linked adrenoleukodystrophy at the age of (b)(6) years.He developed progressive leukodystrophy as typical feature of the underlying disease and bilateral basal ganglion necrosis which we interpreted as consequence of the severe addison crisis.This resulted in a mixed picture of spastic and dystonic-dyskinetic movement disorder, initial gmfcs lay at iii, decreasing to iv.One month after the neurological deterioration, baclofen pump was implanted.Difficulties with the intrathecal baclofen therapy started nearly immediately.The symptoms varied widely with intermittent weakness in the legs.This was interpreted as a sign of overdose.These symptoms alternated with phases of increased spasticity suggesting underdosing.The fluctuating symptoms led to frequent reprogramming of the baclofen pump rate.The dose varied between 25 and 510 mcg/d.Ct was performed because of the unstable treatment results and revealed an epidural position of the dislocated intrathecal catheter.This incorrect positioning most likely resulted in the delivery of changing amounts of intrathecal baclofen which explained the fluctuating symptoms.After revision of the catheter, baclofen was effective at a dose of 350 mcg/d.During follow-up the dose had to be increased only as the disease progressed.Event 6: periventricular leukomalacia because of preterm birth was the cause of bilateral spastic cerebral palsy gmfcs v in this patient.At (b)(6) years, the boy received a baclofen pump.Itb showed a good response until the baclofen pump was changed after 7 years when the battery was low.Three months after changing the pump, the patient developed a spastic crisis.X-ray was inconspicuous without signs of catheter interruption or leakage.A pump malfunction was assumed, and a replacement of the pump was planned.For short-term treatment of the withdrawal symptoms, an additional, external csf catheter was placed to administer baclofen intrathecally which led to a rapid improvement.A new pump was implanted shortly afterwards and was connected to the remaining catheter system.However, during the following 5 months, problems persisted with increased intrathecal baclofen demand, interrupted by phases with signs of overdose as increased fatigue and somnolence.When analyzing the difference between internal and external baclofen administration were twofold: the external catheter was positioned very high, and baclofen was more diluted leading doubled flow velocity.A rostral baclofen distribution problem has been discussed.For that reason a new spinal catheter was positioned to the level of c0/c1, and baclofen was thinned down to 1 mg/ml (compared to the standard dilution of 2 mg/ml) to allow for a reasonable intrathecal flow velocity delivered by the pump.This finally resulted in improvement and stabilization of the previously unfavorable situation.Employing higher flow and extremely high catheter placement intraventricular placement could be avoided, what had been discussed as alternative solution.Conclusion: we describe different causes of itb failure, the resulting symptoms and signs, as well as an approach to troubleshooting.Patients with spasticity gmfcs level iv and v may benefit significantly from itb.However, the benefit should also be balanced against the risk of potentially life-threatening complications.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12102513
• MDR Text Key: 261517679
• Report Number: 2182207-2021-01174
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2021
• 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): Required Intervention
• Patient Age: 11 YR