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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068503001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2012
Event Type  Injury  
Manufacturer Narrative
Date of event: the exact event onset date is unknown.The provided event date of february 8, 2012 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported to boston scientific corporation legal by the patient's legal representation.(b)(6).(b)(4).
 
Event Description
It was reported to boston scientific corporation that a lynx system was implanted during a lynx mid-urethral sling and cystoscopy procedures for the preoperative and postoperative diagnoses of female stress incontinence performed on (b)(6) 2012.Clinical history indicated that the (b)(6) female patient had a positive bonney test; urodynamic studies showed a hypotonic bladder with a stopping and starting stream, very poor flow, but actually complete emptying of the bladder.As reported by the patient's attorney, the patient has experienced an unspecified injury.
 
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Brand Name
LYNX SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
FREUDENBERG MEDICAL MIS INC
2301 centennial boulevard
jeffersonville IN 47130
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16038076
MDR Text Key306063689
Report Number3005099803-2022-07693
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/22/2022
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? No
Device Operator Health Professional
Device Expiration Date07/31/2014
Device Model NumberM0068503001
Device Catalogue Number8503001
Device Lot NumberML00000230
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2022
Initial Date FDA Received12/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2011
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient SexFemale
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