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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Muscular Rigidity (1968); Overdose (1988); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from (b)(6) regarding a patient receiving unknown drug via an implanted pump. It was reported after the patient was having a bit of a nightmare with the baclofen pump. It was noted the pump was increased by another 5% about seven to eight weeks before report date and it became too much. The patient's breathing was affected and their lean to the right was more difficult to correct. By the time the patient managed to get an appointment the breathing had settled down but the spasticity was bad. The patient went to see their healthcare provider three weeks prior to this report and they reduced the pump by 2. 5%. It was also noted the patient was getting really sharp pain in the back of their legs and especially at night when the patient needs two pillows to keep their knees bent and their heels off the bed.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7441202
MDR Text Key105844836
Report Number3007566237-2018-01138
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received05/29/2018
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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