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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC, INC. SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6996SQ58
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: pb1018 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 right ventricular (rv) defibrillation lead had fractured.The lead was capped and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
SUBCUTANEOUS, UNIPOLAR LEAD
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key9088356
Report Number2182208-2019-01696
Device Sequence Number2459910
Product Code LWS
UDI-Device Identifier00721902183072
UDI-Public00721902183072
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/19/2019
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 Date03/28/2015
Device Model Number6996SQ58
Device Catalogue Number6996SQ58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2019
Initial Report FDA Received Date09/19/2019
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
D314DRG ICD, 5076-45 LEAD, 429688 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age52 YR
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