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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION
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MEDTRONIC NEUROMODULATION Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problem Electromagnetic Interference (1194)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
A patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor reported that her healthcare provider mentioned that some previous patient's ins systems impacted by screening devices.The status of the patients is unknown, no additional information is available at the time of this report.No patient symptoms were reported.
 
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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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6213290
MDR Text Key63798370
Report Number3007566237-2016-04584
Device Sequence Number1
Product Code LNQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2016
Initial Date FDA Received12/29/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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