MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-18 for PINNACLE PELVIC FLOOR REPAIR KITS manufactured by Boston Scientific Corporation.
[187953889]
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 upn and lot number; therefore, the lot expiration and device manufacture dates are unknown. The complainant indicated that the device is implanted and 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.
Patient Sequence No: 1, Text Type: N, H10
[187953891]
It was reported to boston scientific corporation that a pinnacle device was implanted into the patient during a posterior pinnacle repair with fixation of the sacrospinous ligament procedure performed on (b)(6) 2009. As reported by the patient's attorney, the patient underwent revision of pinnacle device on an unknown date due to unreported reason. Boston scientific has been unable to obtain additional information regarding the event to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01159 |
| MDR Report Key | 9848000 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2009-03-23 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINNACLE PELVIC FLOOR REPAIR KITS |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN |
| Product Code | OTP |
| Date Received | 2020-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |