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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC, INC. UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6721S-50
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/30/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ddmb1d4 icd, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the epicardial high voltage lead patches had confirmed fractures.The leads were programmed off.The leads were capped and a new lead was implanted.No patient complications have been reported as a result of this event.
 
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Brand Name
UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key10216941
Report Number2182208-2020-01187
Device Sequence Number14021552
Product Code LWS
UDI-Device Identifier00681490148818
UDI-Public00681490148818
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P900061
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/01/2020
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 Date08/31/2003
Device Model Number6721S-50
Device Catalogue Number6721S-50
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/15/2020
Initial Report FDA Received Date07/01/2020
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
6721S-50 LEAD, 4968-35 X2 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age24 YR
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