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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERANTIONAL SARL MEDSTREAM 20 ML IMPLANTABLE DRUG DELIVERY PUMP

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MEDOS INTERANTIONAL SARL MEDSTREAM 20 ML IMPLANTABLE DRUG DELIVERY PUMP Back to Search Results
Model Number 91-4200
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Ventilator Dependent (2395); Loss of consciousness (2418); Lethargy (2560); Hallucination (4428)
Event Date 08/14/2021
Event Type  Injury  
Manufacturer Narrative
At this time, the alleged malfunction is not confirmed as the investigation is pending completion of dhr review and device evaluation. If additional information is received at a later date, a supplemental report will be filed.
 
Event Description
A report was made by a healthcare provider to (b)(6) regarding an alleged malfunction of a medstream implantable infusion pump in a patient. It was reported to bfarm that there was "excessive delivery of a drug (baclofen) of unclear origin by an implanted drug pump codman medstream. Due to a massive overdose in the following days, the patient required ventilation (danger to life) (lz ventilation with tracheostomy). As a result, pneumonia develops. " no additional information was provided with the bfarm report. Intera reached out to the healthcare provider and received the following information: the patient was being treated for spastic tetraplegia from c5 after c5/5 fracture, and was being treated with baclofen in the pump. Baclofen was dosed at 200 micrograms/day. The previous refill occurred on (b)(6) 2021. The patient experienced drowsiness, weakness, difficulty concentrating, had loss of consciousness within 2 days, hallucinations, respiratory failure. Interventions taken included neurological intensive care, ventilation. Current condition of the patient is alert, responsive, oriented, physically still weak with pronounced concentration disorders. The healthcare provider stated that there were no error codes displayed on the pump controller. Pump was reported to be explanted on (b)(6) 2021. The pump was reported not to have visible damage other than scratches on the surface due to the explant procedure. The healthcare provider stated the pump transaction logs were available but has not forwarded them to intera on request at the time of this report. The status of the explanted pump is not known at the time of this report.
 
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Brand NameMEDSTREAM 20 ML
Type of DeviceIMPLANTABLE DRUG DELIVERY PUMP
Manufacturer (Section D)
MEDOS INTERANTIONAL SARL
chemin blanc 38
le locle, 2400
SZ 2400
Manufacturer (Section G)
INTERA ONCOLOGY
65 william street
suite 200
wellesley MA 02481
Manufacturer Contact
sarah lapp
65 william street
suite 200
wellesley, MA 02481
7814895724
MDR Report Key13564864
MDR Text Key285933630
Report Number3015537318-2022-00005
Device Sequence Number1
Product Code LKK
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
P890055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2015
Device Model Number91-4200
Device Lot NumberCHRBMR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2022 Patient Sequence Number: 1
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