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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. UNIPOLAR LEAD BODY TO IS-1 IPG LEAD ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER
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MEDTRONIC, INC. UNIPOLAR LEAD BODY TO IS-1 IPG LEAD ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER Back to Search Results
Model Number 58669M
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the proximal portion of the lead was returned and analyzed.The analysis indicated that the distal conductor of the lead developed a fracture due to flexing while in vivo.The outer insulation of the lead developed a breach due to a depression while in vivo.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The lead was returned, analyzed and tested out of specification.No patient complications have been reported as a result of this event.
 
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Brand Name
UNIPOLAR LEAD BODY TO IS-1 IPG LEAD ADAPTOR KIT
Type of Device
ADAPTOR, LEAD, PACEMAKER
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8477063
MDR Text Key140739613
Report Number2182208-2019-00634
Device Sequence Number1
Product Code DTD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number58669M
Device Catalogue Number58669M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2019
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? Yes
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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