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

Model Number M0068317010

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

Patient Problems Incontinence (1928); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 10/24/2011

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (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) 2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; groin pain; thi pain; pain inter; inab inter; rec incont; aggrav incont; damage; psych; oth pain: general heaviness, numbness.

Manufacturer Narrative

Additional information to blocks a1: patient's initials, b5, b7, d4: lot number, and e1: physician's name and healthcare facility.A1: meshc-20211103-fb0ead43 b3 date of event: date of event was approximated to (b)(6) 2011, the date the sling was implanted, as no event date was reported.E1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).H6: patient codes e2330, e1405 and e0206 capture the reportable events of pain (back pain, pelvic pain, groin pain, thigh pain), dyspareunia (painful intercourse, inability to have intercourse), and unspecified mental, emotional or behavioral problem (psychiatric injury).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.H10: the complaint device is not expected to be returned for evaluation; therefore, 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 duet pelvic floor repair kit was used during an anterior and posterior vaginal repair, mesh, and tension-free vaginal tape, sacrospinous fixation (tvssf) procedure performed on (b)(6) 2011, for the treatment of cystocele and rectocele.The patient experienced complications and nonsurgical treatment.As reported by the patient's attorney, the patient experienced back pain, pelvic pain, groin pain, thigh pain, pain during intercourse, inability to have intercourse, recurrent incontinence, aggravated incontinence, damage, psychiatric injury, other pain, general heaviness, and numbness.

• 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: 12929735
• MDR Text Key: 285616764
• Report Number: 3005099803-2021-06929
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091131
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: M0068317010
• Device Catalogue Number: 831-701
• Device Lot Number: ML00000175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2011
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 75 KG