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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Medtronic, Inc. Patient Connector; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

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Medtronic, Inc. Patient Connector; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS Back to Search Results
Model Number 24967
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/10/2026
Type of Reportable Event Malfunction
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Brand Name
Patient Connector
Common Device Name
PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
Manufacturer (Section D)
Medtronic, Inc.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
Medtronic, Inc.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
gerard torenvliet
8200 coral sea st ne
mounds view, MN 55112--439
+1(763)526-9277
MDR Report Key50219384
Report Number2182208-2026-48894
Device Sequence Number18728422
Product Code OSR
UDI-Device Identifier00763000060428
UDI-Public(01)00763000060428(11)200615
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/12/2026
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
Operator of Device Health Professional
Device Model Number24967
Device Catalogue Number24967
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/10/2026
Initial Report FDA Received Date08/12/2026
Date Device Manufactured06/15/2020
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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