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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. LEAD ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER
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MEDTRONIC, INC. LEAD ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER Back to Search Results
Model Number 2872
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/06/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the left ventricular (lv) lead exhibited a fracture.The lv lead was capped and replaced.It was noted the set screw of the y adaptor was stripped and the leads had to be cut to remove the adaptor.The adaptor was subsequently removed.No patient complications have been reported as a result of this event.
 
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Brand Name
LEAD ADAPTOR KIT
Common Device Name
ADAPTOR, LEAD, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key9122603
Report Number2182208-2019-01740
Device Sequence Number2459446
Product Code DTD
UDI-Device Identifier00681490064583
UDI-Public00681490064583
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K982220
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/28/2013
Device Model Number2872
Device Catalogue Number2872
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/06/2019
Initial Report FDA Received Date09/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ADDRL1 IPG, 4592-45 LEAD, 407452 LEAD, 429688 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age83 YR
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