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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 Obstruction of Flow (2423); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id 8780 lot/serial#: (b)(4) implanted: (b)(6) 2020 explanted: product type catheter, ubd: 21-oct-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2020, information was received from an healthcare professional (hcp) via a manufacturer representative (rep), regarding a patient receiving morphine (10 mg/ml, unknown dose) via an implantable pump for an unknown indication for use. It was reported during implant, the spinal segment of the catheter was difficult to place. After a second attempt, the surgeon felt there was something wrong, so a new segment was opened. The issue was reported as resolved at the time of this report. The patient's status was alive - no injury. Additional information was received from the manufacturing representative (rep). The rep was not sure why there was difficulty placing the catheter. After a few attempts the surgeon said the they though the catheter was kinked. The catheter will be returned for analysis. The information provided was confirmed by the physician/account.
 
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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 Key9836336
MDR Text Key193639133
Report Number2182207-2020-00009
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,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? Yes
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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