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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number NEU_UNKNOWN_CATH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Meningitis (2389)
Event Date 01/01/2009
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was receiving dilaudid and bupivacaine at unknown doses and concentrations via a trial catheter for non-malignant pain. It was reported that the patient got bacterial meningitis when they had the pump trial. It was reported the patient got it from the hospital. The patient was put on antibiotics by the pain management doctor. The patient had a rash on their body, and they thought at the time that it was an allergic reaction to the sheets. It was reported that this occurred in 2009. No further complications were anticipated/reported.
 
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Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7634722
MDR Text Key112214127
Report Number3007566237-2018-01878
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNEU_UNKNOWN_CATH
Device Catalogue NumberNEU_UNKNOWN_CATH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/25/2018 Patient Sequence Number: 1
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