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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 Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from saol therapeutics regarding a patient receiving lioresal (500. 0 mcg/ml at 121. 12 mcg/day) via an implanted pump. It was reported that on (b)(6) 2018, after starting the product, the patient¿s pump battery life was wearing down and the pump was being replaced. On an unspecified date, the patient had been evaluated by the neurosurgeon and they were not certain if the patient would get cardiac clearance for the procedure as he was having some cardiac issues. As such, lioresal may need to be discontinued. The patient was currently taking oral baclofen (dose unknown). The reporter was requesting information on titration. No additional information was provided.
 
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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 Key7622284
MDR Text Key111823426
Report Number3007566237-2018-01844
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 other
Reporter Occupation
Type of Report Initial
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
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: 06/20/2018 Patient Sequence Number: 1
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