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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SYNCHOMED II IMPLANTABLE DRUG INFUSION PUMP; INTRATHECAL PAIN PUMP
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MEDTRONIC, INC. SYNCHOMED II IMPLANTABLE DRUG INFUSION PUMP; INTRATHECAL PAIN PUMP Back to Search Results
Catalog Number 8637-20
Device Problems Premature Discharge of Battery (1057); Battery Impedance Issue (2884)
Patient Problems Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)
Event Date 01/29/2016
Event Type  Injury  
Event Description
Patient had intrathecal pump and catheter placement for post laminectomy syndrome on (b)(6) 2011.Pain relief became inadequate and the patient started experiencing withdrawal.A malfunction of the pump caused pump to be put at minimal rate.It was found that the device's battery had failed.Battery failure was 22 months prior to the expected date of expiration.Patient was admitted (b)(6) 2016 for pump replacement and was discharged (b)(6) 2016 in stable condition.The explanted device was provided to (b)(4), medtronic rep, on 02/02/2016.Report was emailed to ms.(b)(4) on behalf of medtronic.
 
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Brand Name
SYNCHOMED II IMPLANTABLE DRUG INFUSION PUMP
Type of Device
INTRATHECAL PAIN PUMP
Manufacturer (Section D)
MEDTRONIC, INC.
7000 central ave. ne, rce370
minneapolis MN 55432
MDR Report Key5446451
MDR Text Key38643328
Report Number5446451
Device Sequence Number1
Product Code LKK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2017
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Returned to Manufacturer02/02/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2016
Distributor Facility Aware Date01/29/2016
Device Age5 YR
Event Location Home
Date Report to Manufacturer02/04/2016
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age52 YR
Patient Weight83
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