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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) ASSURITY + DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC. (CRM-KISTA) ASSURITY + DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2260
Device Problems Difficult to Interrogate (1331); Loss of Data (2903); Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the pulse generator could not be interrogated using rf communication.Interrogation was achieved through induction and a diagnostic anomaly was discovered.The anomaly was cleared and the device exhibited normal operations.
 
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Brand Name
ASSURITY + DR RF
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
ulla strindlund
box 7051
isafjordsgatan 15
kista SE-16-407
SW   SE-16407
4684744043
MDR Report Key5323513
MDR Text Key34812878
Report Number3010215456-2015-33055
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2016
Device Model NumberPM2260
Device Lot Number4895699
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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