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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PFR KIT PINNACLE LITE POSTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

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BOSTON SCIENTIFIC CORPORATION PFR KIT PINNACLE LITE POSTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Model Number M0068317150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Incontinence (1928); Injury (2348); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
Event Date 01/31/2014
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.Bl this event was reported by the patient's legal representation.The device was implanted 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 pfr kit pinnacle lite posterior was implanted into the patient during a procedure performed on january 31, 2014.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.The patient was also implanted with a non-bsc device on (b)(6) 2014.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 pfr kit pinnacle lite posterior was implanted into the patient during a procedure performed on (b)(6) 2014.The patient was also implanted with a non-bsc device on (b)(6) 2014.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; psychiatric injury.Nonsurgical treatments: on (b)(6) 2015 the patient commenced pain medication: panodol for the treatment of: bladder and back pain.Treatment duration: ongoing.On (b)(6) 2015 the patient commenced incontinence medication: incontinence pads for the treatment of: incontinence.Treatment duration: ongoing.The patient was treated with topical treatment (including oestrogen cream): oestrogen for the treatment of: vaginal dryness.Treatment duration: ongoing.
 
Manufacturer Narrative
Block b3 date of event: date of event was approximated to january 31, 2014, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted by: dr.(b)(6).(b)(6) hospital.Block h6: patient code e2006, e1405, e0206 and e2330 captures the reportable event of erosion, dyspareunia, unspecified mental, emotional or behavioural problem and pain.Impact codes f12 and f2303 captures the reportable event of serious injury/ illness/ impairment and medication required.Block h10: 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.Block h11: block e1: physician's information has been added.Block b5 has been updated.Block h6: patient and impact code are updated.
 
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Brand Name
PFR KIT PINNACLE LITE POSTERIOR
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 Key11177296
MDR Text Key227024613
Report Number3005099803-2021-00042
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K122459
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 11/03/2022
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 Date10/31/2014
Device Model NumberM0068317150
Device Catalogue Number831-715
Device Lot NumberML00000345
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/16/2020
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received10/06/2022
Supplement Dates FDA Received11/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2011
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age78 YR
Patient SexFemale
Patient Weight75 KG
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