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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 Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)
Event Date 01/22/2009
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2009 (implant date), as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The devices were implanted by dr.(b)(6) at (b)(6) health center and were excised by dr.(b)(6) at (b)(6) medical center.Additional lawyer: (b)(6).(b)(4).The excised mesh 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
Note: this pertains to the first of two devices implanted during the same procedure.It was reported to boston scientific corporation that a pinnacle pelvic floor kit and an obtryx devices were implanted during a procedure performed on (b)(6) 2009.The procedure was completed without intraoperative complications.As per reported by the patient's attorney, as a result of the device implantation, the patient has experienced significant mental and physical pain and suffering, has sustained severe and irreversible injury, and permanent and substantial physical deformity.Subsequently, the patient has undergone corrective surgeries and underwent excision of the products on (b)(6) 2018 at a different healthcare facility.Furthermore, she reportedly likely will undergo further corrective surgery or surgeries.Boston scientific has been unable to obtain additional information regarding the event to date.
 
Manufacturer Narrative
Correction to fields d1: brand name; d2: common name and pro code; and d4: model number, catalog number, and udi.Block b3 date of event: date of event was approximated to (b)(6), 2009 (implant date), as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the devices were implanted by (b)(6) and were excised by (b)(6) additional lawyer: (b)(6).Block h6: patient codes 2360, 1994, 3191, and 2348 capture the reportable events of permanent physical deformity, pain, surgical intrventions, and permanent injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh 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
Note: this pertains to the first of two devices implanted during the same procedure.It was reported to boston scientific corporation that a pinnacle pelvic floor kit and an obtryx devices were implanted during a procedure performed on (b)(6) 2009.The procedure was completed without intraoperative complications.As per reported by the patient's attorney, as a result of the device implantation, the patient has experienced significant mental and physical pain and suffering, has sustained severe and irreversible injury, and permanent and substantial physical deformity.Subsequently, the patient has undergone corrective surgeries and underwent excision of the products on (b)(6) 2018 at a different healthcare facility.Furthermore, she reportedly likely will undergo further corrective surgery or surgeries.Boston scientific has been unable to obtain additional information regarding the event to date.
 
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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
MDR Report Key9533739
MDR Text Key183915122
Report Number3005099803-2019-06258
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K071957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM0068317050
Device Catalogue Number831-705
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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