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

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.

Event Description

The device was reported to be in the possession of the patient, and thus not available for evaluation.

Manufacturer Narrative

The device was reported to be in the possession of the patient and subsequently not available for further evaluation.The root cause of the alleged device malfunction is not confirmed.A review of the manufacturing lot history showed that there were no nonconformities of the device as manufactured; the device met all product specifications.The medstream pump product line was discontinued in 2014.Blank fields in the mdr form represents unknown information at the time of report filing.If further information is received, a supplemental report will be filed.

• Brand Name: MEDSTREAM 20 ML
• Type of Device: IMPLANTABLE 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 Key: 13564864
• MDR Text Key: 285933630
• Report Number: 3015537318-2022-00005
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 91-4200
• Device Lot Number: CHRBMR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2014
• 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): Life Threatening
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 45 KG