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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

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MEDTRONIC, INC. MEDTRONIC IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number MDT-IPG
Device Problems High impedance (1291); Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2024
Event Type  malfunction  
Manufacturer Narrative
A voluntary medwatch form 3500 was received (report #mw5152534); since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was reported that the implantable pulse generator (ipg) exhibited a intermittent high impedance value.It was noted that the ipg remains in use. no patient complications have been reported as a result of this event.
 
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Brand Name
MEDTRONIC IPG
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key19057816
MDR Text Key339559776
Report Number2182208-2024-01500
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/08/2024
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 Lay User/Patient
Device Model NumberMDT-IPG
Device Catalogue NumberMDT-IPG
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/08/2024
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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