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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number NEU_UNKNOWN_PUMP
Device Problems Application Program Problem (2880); Communication or Transmission Problem (2896); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2021
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: a810, serial#: unknown, product type: software, ubd: n/a, udi#: n/a. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a device manufacturer representative (rep) regarding a patient receiving therapy via an implantable infusion pump. It was reported that post new implant when the pump was attempted to be updated the error codes 102 (pump is detected to be in a temporary stop state during interrogation) and 140 (update did not complete) appeared. The caller was advised to exit the application and attempted to update the pump while in stopped mode but the issue remained along with a new error code 114 (pump memory error). The rep was then walked through programming the pump to lowest simple continuous, programming the lowest single bolus possible and enabling the personal therapy manager (ptm). This corrected the issue and rep was able to reprogram the pump successfully. Additional information was received from the manufacturing representative (rep). The rep reached out to the managing physician's office and the office stated the pump was working fine and there were no further issues. The office declined to provide any further information.
 
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Brand NameIMPLANTABLE DRUG INFUSION PUMP
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11204718
MDR Text Key227974321
Report Number2182207-2021-00100
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2021
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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