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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC NANOSTIM LEADLESS PACEMAKER DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD

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ST. JUDE MEDICAL, INC NANOSTIM LEADLESS PACEMAKER DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD Back to Search Results
Catalog Number S1DLCP
Event Date 03/10/2015
Event Type  Injury  
Event Description

A intra-ventricular pacemaker was to be placed in the patient. It was dislodged and advanced into the pulmonary artery. The doctor attempted to retrieve it and was unable to retrieve the device. It remained in the patient. Ir to attempt removal the following day. Patient was admitted to the icu and they were later able to successfully remove the device.

 
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Brand NameNANOSTIM LEADLESS PACEMAKER
Type of DeviceDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD
Manufacturer (Section D)
ST. JUDE MEDICAL, INC
15900 valley view ct.
sylmar CA 91342
MDR Report Key4647578
Report Number4647578
Device Sequence Number1
Product CodeDXY
Report Source User Facility
Type of Report Initial
Report Date 03/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberS1DLCP
Device LOT NumberNEN141028A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2015
Event Location Hospital
Date Report TO Manufacturer04/01/2015

Patient TREATMENT DATA
Date Received: 03/26/2015 Patient Sequence Number: 1
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