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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068502000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Rash (2033); Urinary Retention (2119); Numbness (2415); Dysuria (2684)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
Health(b)(6) incident report reference no.(b)(4); submitted to health (b)(6) by the patient.(b)(4).The device was implanted and is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an advantage system was implanted into the patient during a procedure performed on (b)(6) 2017.On (b)(6) 2017, the patient experienced groin pain and constant slenderness of the right side, then from front to back.She also had slenderness and numbness from the right leg down to the foot while sitting, standing or lying down.Moreover, the patient had bad lower back, hives, and extreme fatigue which made her going about her day difficult.She experienced pain when urinating and her bladder would not empty the first time, either she had to wait a little on the toilet or had to go the second time.Reportedly, the patient experienced psychological difficulties due to pain and she no longer has the endurance that she had.
 
Manufacturer Narrative
Correction to block h6: the event of hives will be captured under e0402: hypersensitivity/allergic reaction instead of e1714: rash.Also, the event of slenderness and numbness from the right leg down to the foot will be captured under e0123: nerve damage instead of e0127: numbness.Block g3: other: health canada incident report reference no.(b)(4); submitted to health canada by the patient.Block h6: patient codes e2330, e1309, e0402, and e0123 capture the reportable events of groin pain, urinary retention, hives, and slenderness and numbness from the right leg down to the foot.Impact codes f1202 and f12 capture the reportable events of impairment in performing daily life functions and psychological difficulties.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device was implanted and is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an advantage system was implanted into the patient during a procedure performed on (b)(6) 2017.On (b)(6) 2017, the patient experienced groin pain and constant slenderness of the right side, then from front to back.She also had slenderness and numbness from the right leg down to the foot while sitting, standing or lying down.Moreover, the patient had bad lower back, hives, and extreme fatigue which made her going about her day difficult.She experienced pain when urinating and her bladder would not empty the first time, either she had to wait a little on the toilet or had to go the second time.Reportedly, the patient experienced psychological difficulties due to pain and she no longer has the endurance that she had.
 
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Brand Name
ADVANTAGE 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
MDR Report Key12140641
MDR Text Key260698562
Report Number3005099803-2021-03349
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729470274
UDI-Public08714729470274
Combination Product (y/n)N
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/17/2019
Device Model NumberM0068502000
Device Catalogue Number850-200
Device Lot Number0000031364
Was Device Available for Evaluation? No
Date Manufacturer Received07/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
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