BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-705 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 11/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported to boston scientific corporation that a pinnacle was implanted into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; groin pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; psych; oth pain: most discomfort was being the first surgery and correction surgery have not removed implant.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pelvic, back and hip pain.Treatment duration: as necessary.The patient was treated with other (please specify) for the treatment of: urinary symptoms.
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Manufacturer Narrative
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Block a1: (b)(4).Block d4, h4: 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.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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06525.
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Event Description
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It was reported to boston scientific corporation that a pinnacle was implanted into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; groin pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; psych; oth pain: most discomfort was being the first surgery and correction surgery have not removed implant.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pelvic, back and hip pain.Treatment duration: as necessary.The patient was treated with other (please specify) for the treatment of: urinary symptoms.
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Search Alerts/Recalls
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