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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SENSIGHT
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MEDTRONIC NEUROMODULATION SENSIGHT Back to Search Results
Model Number B32000
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported that the burr hole clip that pinches the lead does not close.It is unknown if there were any environment, external, and patient factors that may cause the event.The device was replaced and the issue was resolved.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SENSIGHT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13499814
MDR Text Key290458558
Report Number2182207-2022-00230
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/09/2022
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 Expiration Date07/21/2023
Device Model NumberB32000
Device Catalogue NumberB32000
Device Lot Number082M20221
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received02/09/2022
Date Device Manufactured07/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexFemale
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