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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Model Number M0068317100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Insufficient Information (4580)
Event Date 08/22/2011
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2011, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implantation procedure was performed at (b)(6).(b)(4).The complaint device 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 a pinnacle pelvic floor repair kits was implanted into the patient during a posterior vaginal repair with mesh procedure performed on (b)(6) 2011 to treat rectocele.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.
 
Event Description
It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits was implanted into the patient during a posterior vaginal repair with mesh procedure performed on (b)(6) 2011 to treat rectocele.As reported by the patient's attorney, the patient has experienced an unspecified injury.
 
Manufacturer Narrative
Correction to blocks g2: report source and e1 (below) block b3 date of event: date of event was approximated to august 22, 2011, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: robyn leake, md (b)(6) hospital.Block h6: patient code 2348 captures the reportable event of the unspecified injury.Impact code f12 has been used in the light of the patient seeking legal recourse for an unspecified personal injury related to the device.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.The complaint device 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.
 
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Brand Name
PINNACLE PELVIC FLOOR REPAIR KITS
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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 Key11135489
MDR Text Key226002598
Report Number3005099803-2020-06544
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K071957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2014
Device Model NumberM0068317100
Device Catalogue Number831-710
Device Lot NumberML00000064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2011
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
Patient SexFemale
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