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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. LEAD EXTENDER KIT; ADAPTOR, LEAD, PACEMAKER
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MEDTRONIC, INC. LEAD EXTENDER KIT; ADAPTOR, LEAD, PACEMAKER Back to Search Results
Model Number 6984M
Medical Device Problem Codes Difficult or Delayed Positioning (1157); Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 200h18 tissue valve, implanted (b)(6) 2014; 4965-15 lead, implanted (b)(6) 2011; 200h14 tissue valve, implanted: (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the lead extender was fractured/ loose resulting in the right atrial (ra) lead not functioning correctly.The lead was capped.No patient complications have been reported as a result of this event.
 
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Brand Name
LEAD EXTENDER KIT
Common Device Name
ADAPTOR, LEAD, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key8715582
Report Number2182208-2019-01110
Device Sequence Number16660385
Product Code DTD
UDI-Device Identifier00681490153621
UDI-Public00681490153621
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K915724
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/20/2019
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 Health Professional
Device Expiration Date03/14/2014
Device Model Number6984M
Device Catalogue Number6984M
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2019
Initial Report FDA Received Date06/20/2019
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
407652 LEAD, ADDRS1 IPG
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age8 YR
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