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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 M0068317050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Anxiety (2328); Injury (2348); Depression (2361); Sleep Dysfunction (2517); Dysuria (2684)
Event Date 01/23/2017
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2011 (implant date) as no event date was reported.(b)(4).The complainant indicated that the device is not available for return; 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 kit was implanted into the patient on (b)(6) 2011.As reported by the patient's attorney, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
 
Manufacturer Narrative
Blocks b2 (outcomes attrib to adv event), b3, b5, b7, h6: patient and impact codes have been updated based on the additional information received on august 24, 2022.Correction to blocks e4 and g2.Block g2 - "company representative" has been removed.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6) by dr.(b)(6).Block h6: patient codes e1301; e020202; e2330; and e1310 capture the reportable events of dysuria; depression requiring duloxetine; pain; and urinary tract infection.Impact code f2303 captures the reportable events of medications such as trimethoprim and duloxetine.Block h10: the complaint device is not expected to be returned; 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 kit was implanted into the patient on (b)(6) 2011.As reported by the patient's attorney, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.Additional information received on august 24, 2022: the patient experienced pain on her right side due to constriction of her previous mesh.Subsequently, she had tight mesh removal and insertion of pinnacle mesh.A letter from a psychiatrist dated (b)(6) 2017 mentioned that the patient presented distressed and teary.She reported fluctuating but predominantly depressed and anxious.She claimed that she had difficulties with her sleep, low energy level and poor motivation.She had been struggling with issues related to chronic pain related to previous gynecological surgeries.Her initial work-related injury occurred in 2010, prior to pinnacle implant.She experienced vaginal and bladder prolapse due to heavy lifting, leading to several repair surgeries with additional complications.To further address the issues related to her chronic pain, she attended adapt program in 2016, which she found beneficial and for which she was able to comply the requirements to return to work until november 2016.She claimed suffering from urti (upper respiratory tract infection) which forced her to stop her exercise program and subsequently led to pain aggravation.Simultaneously with her attempt to "get on top of things," she experienced pressure from employer to comply with regular increase in her working hours in order to return to required full time duties.The patient struggled to assert herself and found it more difficult to deal with relapsing pain issues.Medication noted during the visit: duloxetine 30mg capsules 1 mane, duloxetine an 60mg capsules 1 daily.Plan at that time: - increasing her dose of duloxetine to 90mg in the morning and 30 mg at night.- reduction in her working hours was recommended rather than increase in order to give her time and space to continue implementing her recovery plan.- she was also encouraged to reconnect with her psychologist for ongoing support.She had a follow-up appointment scheduled with pain specialist in february.Regular monitoring of her mental state and response to increase in medication.On (b)(6) 2019, the patient presented for a follow-up of her left fifth metatarsal fracture.At that time, it was noted that the fracture had healed.The patient has had feet for the past few weeks and could walk normally with no pain.Notes from the physician during the visit indicated lower abdominal pain, frequency, dysuria and urinary tract infection for which she was advised to try trimethoprim 300mg once daily.She was also permitted to work.
 
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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 Key11175555
MDR Text Key227015666
Report Number3005099803-2020-06704
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 09/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2014
Device Model NumberM0068317050
Device Catalogue Number831-705
Device Lot Number1ML1022204
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2011
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age56 YR
Patient SexFemale
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