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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION N'VISION PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8870
Device Problem Application Program Problem (2880)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8637-40, serial# (b)(4), implanted: (b)(6) 2014, product type: pump. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2021-jan-05, information was received from a healthcare provider (hcp), regarding a patient receiving dilaudid (1. 2 mg/ml, 0. 3476 mg/day) and baclofen (500 mcg/ml, 145 mcg/day) via an implantable pump for intractable spasticity and multiple sclerosis. It was reported the patient's pump reached eri and when the caller interrogated the pump, the "schedule to replace pump by" date was missing. The caller confirmed that the patient had been in the hospital and the pump was updated multiple times between (b)(6) and (b)(6). The pump logs confirmed the updates and the eri alarm log was not showing. The oldest logs were from (b)(6) 2020. The caller stated that the pump was scheduled to be replaced in february. It was reviewed for the caller to contact the hcp that did the pump updates in the hospital to confirm actual eos date, as they might have a report that shows it. No symptoms or patient complications reported.
 
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Brand NameN'VISION
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 Key11231707
MDR Text Key229389630
Report Number2182207-2021-00140
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8870
Device Catalogue Number8870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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