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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_PUMP
Device Problem Contamination (1120)
Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); Meningitis (2389)
Event Date 11/23/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from consumer on 2018-jan-08 reported the patient identifying information. Further information was asked/requested and the patient declined to provide further information at this time and stated they will call back. No further complications were reported/anticipated.
 
Manufacturer Narrative
The main component of the device system; the other relevant components include: product id: neu_unknown_cath, serial# unknown, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Information was received from a user facility regarding a patient receiving an unknown drug with an unknown dose and concentration via an implantable pump for no known indication for use. It was reported the patient experienced a deep sedated staph and bacterial meningitis due to contaminated device implant 3 weeks earlier. It was noted that it was a patient pump. The patient experienced hospitalization and the event was noted as life threatening. The event date was (b)(6)2017. No symptoms were reported. No further complications were reported/anticipated.
 
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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 Key7165614
MDR Text Key101657704
Report Number3007566237-2018-00067
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_UNKNOWN_PUMP
Device Catalogue NumberNEU_UNKNOWN_PUMP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
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: 01/04/2018 Patient Sequence Number: 1
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