NA 91-4205USRecalls & reported problems
Medos International Sàrl · Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704064947), received between May 20, 2019 and May 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Application Program Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2019Application Program Problem; Application Program Problem
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE MEDSTREAM CONTROL UNIT (914205 / SERIAL#: (B)(4) / LOT# CDCDT2) WAS DEFECTIVE; THE CONTROL UNIT SUSPENDS THE PROGRAMMING PROCESS. IT WAS REPORTED THAT THE DEVICE WAS ABLE TO COMMUNICATE WITH THE MEDSTREAM PUMP AND LIKELY THAT THE ISSUE WAS RELATED TO THE BATTERY AS THE DEVICE WAS LOADED REGULARLY. THE PROGRAMMING WAS CORRECT BUT THEN DROPS OUT. THERE WAS NO DISRUPTION OF THE BACLOFEN TREATMENT AS THE SALES REPRESENTATIVE HAD ANOTHER CONTROL UNIT AVAILABLE AND THIS UNIT DID NOT HAVE ANY PROGRAMMING LIMITATION. THERE WAS NO REPORT OF ANY PATIENT INJURY RELATED TO THE REPORTED EVENT WITH THE CONTROL UNIT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8624505 ↗
Other PUMP, INFUSION, IMPLANTED, PROGRAMMABLE devices
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall7 deaths4,929 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
- SYNCHROMED ® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths4,119 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls10 deaths3,054 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths3,084 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls1 death2,588 reports
- SynchroMed® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths2,291 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall3 deaths2,242 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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