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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problems Difficult to Insert (1316); Sticking (1597); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2016
Event Type  malfunction  
Event Description
It was reported that during a first implant surgery, the surgeon had difficulties to insert the lead into the generator block.It was reported that during the surgery on (b)(6) 2016, the lead got stuck and it wouldn't completely go into the receptor head of the generator.The grub screw was lost out of the head and both lead and generator had to be replaced.It was reported that both products (generator and lead) are still at the hospital for examination to see if there is any defect.No further information was provided to date.
 
Manufacturer Narrative
Udi number: (b)(4).
 
Event Description
Further information was received from a nurse, indicating that the suspected device will be returned to the manufacturer for analysis.It was reported that when the reported issue was found, another device was implanted instead.Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.
 
Event Description
The suspected generator and lead were returned to the manufacturer on 09/26/2016.An analysis was completed on the returned lead portions and the reported "insertion difficulties" (lead section) allegation was not confirmed.The connector pin section including the small front o-ring and large o-rings was not returned.A portion of the connector boot was returned.The condition of the returned lead portions is consistent with conditions that typically exist following an attempted implant procedure.No obvious anomalies were noted.Continuity checks of the returned portions were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest a product anomaly with the returned portions of the lead which may have contributed to the stated complaint.An analysis was completed on the returned generator and the reported allegation of "insertion difficulties" was not duplicated in the laboratory.No obstructions were observed in the pulse generator header lead cavity or the connector blocks.The in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions).The pulse generator header lead cavity (critical dimension 1) accepts a pin gauge of 0.136 inches minus (limits 0.137 +/- 0.002).The pulse generator header lead cavity, critical dimension 1, meets specification.In addition, review of the ram/flash data downloaded from the pulse generator shows an impedance test was performed on the date of the attempted implant ((b)(6) 2016).The "time stamp impedance diagleadzhistory" results show: impedance value (ohms): 14240 - time stamp: (b)(6) 2016.This would suggest the lead pin was inserted into the pulse generator header.The reported allegation of "detachment of component(s) set screw" was not duplicated in the laboratory.The septum was cored and damaged on the underneath side.This suggests that the setscrew was extracted up into the septum.This may be the contributing factor for allegation of "detachment of component(s) set screw".The pulse generator performed according to functional specifications.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 0.767% of the battery had been consumed.There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties.First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of.135 max, it may cause insertion difficulty.Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling.It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed.Review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication.No further relevant information has been received to date.
 
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Brand Name
LEAD MODEL 303
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key5893260
MDR Text Key53626777
Report Number1644487-2016-01897
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup,Followup
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/24/2000
Device Model Number303-20
Device Lot Number300428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2016
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 08/11/2016
Initial Date FDA Received08/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
01/22/2018
Supplement Dates FDA Received09/19/2016
10/17/2016
02/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age44 YR
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