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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/20/2012
Event Type  Injury  
Manufacturer Narrative

 
Event Description

On (b)(4) 2013 information was received by the reporter at a physician office visit that the patient had his device disabled in (b)(6) 2012 due to pain he was experiencing. Attempts for additional information are still in continuation.

 
Manufacturer Narrative

Analysis of programming history.

 
Event Description

On (b)(6) 2013 information was received from the reporter that the patient¿s pain had first been observed on (b)(6) 2012 and was categorized as pain and shortness of breath. It was determined that the pain occurred whenever stimulation occurred or whenever the magnet was swiped. It was also noted that the patient had a cardiac stent implanted several days prior to the onset of pain. No further interventions have been taken or are planned since the device was disabled. No causal or contributory programming or medication changes preceded the onset of the pain. A manufacturer's review of the programming history database showed that programming history data is available from (b)(6) 2006 (date of implant) to (b)(6) 2009. Follow-up also provides data from (b)(6) 2012.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3167203
Report Number1644487-2013-01756
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015227
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/05/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/13/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/13/2013 Patient Sequence Number: 1
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