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

Model Number M0068317150

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

Patient Problems Incontinence (1928); Laceration(s) (1946); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Discomfort (2330); Constipation (3274); Dyspareunia (4505)

Event Date 03/12/2013

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle lite was implanted on (b)(6) 2013.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; other pain: butt cheek; painful intercourse; inability to have intercourse; difficulties with bowel motions; aggravated incontinence nonsurgical treatments: on (b)(6) 2013 the patient commenced pain medication: nurofen for the treatment of: pain - (allergic reaction to codeine).On (b)(6) 2013 the patient commenced other medication (please specify): lactulose oral liquid for the treatment of: loosen stools.Treatment duration: 6 weeks.On (b)(6) 2013 the patient commenced topical treatment (including oestrogen cream): lignocaine gel for the treatment of: viginal dryness.Treatment duration: 6 weeks.On (b)(6) 2013 the patient commenced other medication (please specify): movical for the treatment of: loosen stools.Treatment duration: to present date.

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.

Manufacturer Narrative

Block a1: (b)(6).Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h10: 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.Block h11: blocks b5, h6 (patient codes), and h10 have been corrected based on the medical safety review received on september 16, 2022.Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2330 captures the reportable event of pain.Patient code e1309 captures the reportable event of urinary retention.Patient code e1401 captures the reportable event of abnormal vaginal discharge.Patient code e2009 captures the reportable event of lacerations (fissure).Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that a pinnacle lite was implanted on (b)(6) 2013.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; other pain: butt cheek; painful intercourse; inability to have intercourse; difficulties with bowel motions; aggravated incontinence nonsurgical treatments: on (b)(6) 2013 the patient commenced pain medication: nurofen for the treatment of: pain - (allergic reaction to codeine).On (b)(6) 2013 the patient commenced other medication (please specify): lactulose oral liquid for the treatment of: loosen stools.Treatment duration: 6 weeks.On (b)(6) 2013 the patient commenced topical treatment (including oestrogen cream): lignocaine gel for the treatment of: viginal dryness.Treatment duration: 6 weeks.On (b)(6) 2013 the patient commenced other medication (please specify): movical for the treatment of: loosen stools.Treatment duration: to present date.***additional information received on august 19, 2022*** the procedures performed on (b)(6) 2013 were posterior vaginal repair with mesh kit (pinnacle - lite) implant, anterior vaginal repair, and cystoscopy to treat a patient with prolapse and a large rectocele.On (b)(6) 2013, the patient presented to the emergency department (ed) and was experiencing fecal impaction and urinary retention post gynae surgery.Postoperatively, patient was reported to void 220 ml post trial of void and it was noted to be borderline for indwelling catheter.The patient was discharged on tramadol and lidocaine cream (for urethra).At the ed, the patient reported that she had not passed decent bowel action since the operation and her urinary symptoms (retention, discomfort) were worsening.In addition to the patient's urinary retention, the patient was experiencing discomfort and perianal pain fissure when straining to defecate.She also reported a decreasing amount of yellow vaginal discharge since the procedure.The patient reported lack of progress.Her main complaint was the pain.Upon systems review, the patient did not have fever and there was no dysuria noted.Upon observation and general examination, the patient looked uncomfortable when walking and the patient cannot sit.Upon abdominal examination, the abdomen was tender along the suprapubic region.There was palpable faecal loading on the left.During bladder scan, it was noted that there was >600 ml.Post voiding residual urine was 220 ml.Upon neurological and spine examination, the sensation and power in the lower limb was noted to be normal.The patient's provisional diagnosis was urinary post operative faecal impaction secondary to urinary retention and symptoms of anal fissure.The patient's management and treatment plan included contacting the gynae registrar prior to pr examination or administering pr treatments.The gynae registrar would come and review.Results and outcome include axr, faecal loading especially in the rectum.Gynae team reviewed.In light of protracted history and complications, they have suggested tf to moorabbin for in patient treatment of constipation.The patient was agreeable.Aperients and anaemias charted.

Event Description

It was reported to boston scientific corporation that a pinnacle lite was implanted on (b)(6) 2013.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; other pain: butt cheek; painful intercourse; inability to have intercourse; difficulties with bowel motions; aggravated incontinence.Nonsurgical treatments: on (b)(6) 2013 the patient commenced pain medication: nurofen for the treatment of: pain - (allergic reaction to codeine).On (b)(6) 2013 the patient commenced other medication (please specify): lactulose oral liquid for the treatment of: loosen stools.Treatment duration: 6 weeks.On (b)(6) 2013 the patient commenced topical treatment (including oestrogen cream): lignocaine gel for the treatment of: viginal dryness.Treatment duration: 6 weeks.On (b)(6) 2013 the patient commenced other medication (please specify): movical for the treatment of: loosen stools.Treatment duration: to present date.Additional information received on august 19, 2022.The procedures performed on (b)(6) 2013 were posterior vaginal repair with mesh kit (pinnacle - lite) implant, anterior vaginal repair, and cystoscopy to treat a patient with prolapse and a large rectocele.On (b)(6) 2013, the patient was experiencing fecal impaction and urinary retention post gynae surgery.The patient was reported to void 220 ml post trial of void and it was noted to be borderline for indwelling catheter.The patient reported that she had not passed decent bowel action since the operation and her urinary symptoms were worsening.In addition to the patient's urinary retention, the patient was experiencing discomfort and perianal pain fissure when straining to defecate.The patient was discharged on tramadol and lidocaine cream (for the urethra).The patient reported lack of progress.Her main complaint was the pain.Upon systems review, the patient did not have fever and there was no dysuria noted.Upon observation and general examination, the patient looked uncomfortable when walking and the patient cannot sit.Upon abdominal examination, the abdomen was tender along the suprapubic region.There was palpable faecal loading on the left.During bladder scan, it was noted that there was >600 ml.Post voiding residual urine was 220 ml.Upon neurological and spine examination, the sensation and power in the lower limb was noted to be normal.The patient's provisional diagnosis was urinary post operative faecal impaction secondary to urinary retention and symptoms of anal fissure.The patient's management and treatment plan included contacting the gynae registrar prior to pr examination or administering pr treatments.The gynae registrar would come and review.Results and outcome include axr, faecal loading especially in the rectum.Gynae team reviewed.In light of protracted history and complications, they have suggested tf to moorabbin for in patient treatment of constipation.The patient was agreeable.Aperients and anaemias charted.

Manufacturer Narrative

Block a1: (b)(6).Block h10: 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.Block h11: blocks a1, b5, b7, d1, d4, d6a, g1, h4, h6 (patient code), and h10 have been updated based on the additional information received on august 19, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) md (b)(6) medical center - (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2330 captures the reportable event of pain.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

• 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 Key: 12930614
• MDR Text Key: 286507803
• Report Number: 3005099803-2021-07037
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• 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,Followup
• Report Date: 10/13/2022

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: 06/30/2014
• Device Model Number: M0068317150
• Device Catalogue Number: 831-715
• Device Lot Number: ML00000181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 08/19/2022; 09/16/2022
• Supplement Dates FDA Received: 09/15/2022; 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2011
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 50 KG