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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)
Patient Problems Dyspnea (1816); Fatigue (1849); Memory Loss/Impairment (1958); Overdose (1988); Seizures (2063); Seroma (2069); Visual Disturbances (2140); Weakness (2145); Twitching (2172); Headache, Lumbar Puncture (2186); Dysphasia (2195); Brain Injury (2219); Complaint, Ill-Defined (2331); Depression (2361); Numbness (2415); Loss of consciousness (2418); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Diminished Pulse Pressure (2606)
Event Type  Injury  
Manufacturer Narrative
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 dilaudid and bupivacaine via an implanted pump.It was reported the patient presented to the clinic for a refill on (b)(6) 2017.It was noted 23 ml was aspirated from the pump.A mixture of 0.5 mg/ml of dilaudid and 30 mg/ml of bupivacaine was injected.It was noted the medication was injected in "increments", with "intermittent aspiration." the records also document that the pain pump was reprogrammed.It was mentioned a potentially lethal dose of pain medication was injected, misdirected, and negligently placed into the patient's body.The patient developed a seroma around the area of the pain pump.Shortly after the medication was injected, the patient lost feeling in their legs.The patient then lost feeling in their torso and upper extremities.Ems was called due to the severe and life-threatening symptoms the patient experienced following the injection.The patient's symptoms worsened quickly as they developed severe shortness of breath and their systolic blood pressure dropped.The patient was given 15 mg of ephedrine and was placed on supplemental oxygen.The patient was taken to the hospital and note from the refill nurse noted the patient complained of complete numbness from midline of their stomach down to both feet following pump refill.The patient was unable to move or wiggle their toes.The patient's vitals were table and after ems was called the patient complained of slurred speech and numbness/weakness in their hands.A iv was started in the right had with 0.9 normal saline running.The nurse provided a note explained that likely due to an inappropriate deposition of medication but would rule out any other possible causes.Per ems, the patient began to exhibit loss of motor function on b/l upper and lower extremities in the ambulance, as well as being unable to speak.The patient arrived to the ed unresponsive.The patient arrived with the chief complaint of altered mental status.The patient was diagnosed with an "accidental bupivacaine overdose" and an "opiate overdose, accidental or unintentional." the patient was given narcan in an attempt to reverse the effects of the overdose.The patient had improvement of their respirations but then began to have twitching of their hands and rotary nystagmus.The patient was given ativan with improvement.The records showed the patient also had a seizure/tremors.The patient was still not responding so they were intubated.Neurosurgery was called to remove the medication but they were unable to.The patient was taken to fluoroscopy, but they also were unable to remove medication from the pain pump so a lumbar puncture was done.It was noted the qrs was not significantly widened and no further seizure activity was noted.Poison control was contacted and it was recommended to start bicarb if qrs widens and intralipids if seizures become intractable.The patient was admitted to the hospital.It was noted afterwards the patient was still unable to move their lower extremities but was able to shake their head in response to "yes" or "no" questions.On (b)(6) 2017, the pump was evaluated and found to be functioning normally.Fluid collection was found around the pump and 18 ml of dilaudid/bupivacaine remained in the pump.It was determined that two things occurred.First, none of the medication was removed from the pump as initially thought, during the attempted pump re-fill.In addition, it was felt that none of the medication injected on (b)(6) 2017 went into the pump, but rather it all collected around the pump in the tissues.It is hypothesized that the medication likely tracked along the catheter into the intrathecal space, causing quadriparesis.No further medication was put in the pump and the patient was to follow-up with their managing physician to have the pump filled.The patient was discharged from the hospital on (b)(6) 2017.It was noted the patient had regained their strength but still had some sensations of felling off and fatigue.On (b)(6) 2018, the patient presented for neuropsychological testing with the hcp due to memory loss and cognitive changes.The patient was diagnosed with a neurocognitive disorder, likely due to an anoxic brain injury.The patient was also found to have a personality change, likely due to an anoxic brain injury.The patient was recommended to go to speech and cognitive therapy.The patient hoped therapy would help the patient return to normal but it appears the injuries and deficits were permanent.The patient is depressed and has an unusual affect.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10307548
MDR Text Key199860190
Report Number3004209178-2020-12605
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2020
Date Device Manufactured10/31/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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