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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number NEU_UNKNOWN_PUMP
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via an email regarding a patient receiving an unknown medication via an implanted pump. The indication for pump use was not reported. On (b)(6) 2018, the reporter wanted to know if a pump failed and was in safe mode if it could start up again. No patient symptoms were reported and no additional information was provided.
 
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Brand NameIMPLANTABLE PUMP
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 Key7248460
MDR Text Key99243119
Report Number3007566237-2018-00382
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 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
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 Received02/01/2018
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

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