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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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MEDTRONIC, INC. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Material Too Rigid or Stiff (1544); Inaccurate Delivery (2339)
Patient Problem No Code Available (3191)
Event Date 07/11/2019
Event Type  malfunction  
Event Description
Had medtronic intrathecal baclofen pump implanted (b)(6) 2012, replaced (b)(6) 2019 without incident for end of life, filled with 40ml of 2gm/ml solution (gablofen from piramal).Had rate increase (b)(6) 2019.With increase rate from 175 mcg/d to 185mcg/d.Returned (b)(6) 2019 for refill of pump at 6 month interval, reported mildly stiffer.Found 39.5 ml in pump (40 ml reservoir); pump computer calculated should be 23.7ml.Logs report no malfunction, no alarms triggered.Xray showed no systems defects.Pump replaced (b)(6) 2019, system appeared intact.Pump returned to medtronic, evaluation report received later of no defect found, so remain with no explanation for the pump failure to deliver medicine which should have emptied the reservoir.Fortunately, patient¿s apparent withdrawal was mild.Improved with new pump.Fda safety report id # (b)(4).
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC, INC.
minneapolis MN 55432
MDR Report Key9467067
MDR Text Key171623094
Report NumberMW5091652
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/11/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2019
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age18 YR
Patient Weight55
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