MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 08/21/2012

Event Type  Injury  

Manufacturer Narrative

(b)(6) the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.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 implant was implanted into the patient on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; rect pain; thi pain; inab inter; off vag dis; diff bowel; rec incont; damage; psych;.

Manufacturer Narrative

Blocks a1 (patient identifier), b2, b5, d4, e1, h4 and g1 have been updated based on the additional information received august 21, 2012.Block a1: meshc-20211105-7905a5b6.D4 (model number): m0068317100.D4 (lot number): ml00000302.D4 (expiration date): 09/30/2014.G1 (mfr site information): mfr site facility name: freudenberg medical mis inc.Mfr site address 1: 2301 centennial boulevard.Mfr site city: jeffersonville.Mfr site state: in.Mfr site zip/post code: 47130.Mfr site country: united states.H4 (device manufacturer date): 09/27/2011 block b3 date of event: date of event was approximated to august 21, 2012, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr (b)(6).Block h6: patient codes e2330, e1405, and e0206 capture the reportable events of pain (back pain, vaginal pain, rectal pain, thigh pain), dyspareunia (inability to have intercourse),and unspecified mental, emotional or behavioural problem (psychiatric injury).

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 (pinnacle), and bilateral sacrospinous fixation with mesh tape on (b)(6) 2012.The patient had recto-enterocele and sensation of tenesmus.Post-operative findings showed that large rectocele and enterocele, deficient perineal body with scarring from obstetric tears, and an adequate support of anterior vaginal wall.Post-procedure, the patient experienced complications and nonsurgical treatment(s).Patient symptoms include: back pain, vaginal pain, rectal pain, thigh pain, inability to have intercourse, offensive vaginal discharge, difficulties with bowel motions, recurrent incontinence, and psychiatric injury.

• 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 Key: 12927309
• MDR Text Key: 286342616
• Report Number: 3005099803-2021-06651
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

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 Date: 09/30/2014
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Device Lot Number: ML00000302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 60 KG