MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2009-02-25 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.
[17864962]
Note: the event occurred in 2007; the actual event date is unknown. It was reported to boston scientific corporation approx eight months later, that an enteryx procedure kit was implanted (female patient; age and weight are unknown). According to the complainant, the patient received an enteryx procedure kit in 2004 and in march 2007, the patient had met with her physician due to "on-going terrible upper stomach pain, abdominal pressure and nausea etc... ". A ct scan was performed and the physician reported "seeing a metal surgical clip at the esophageal junction. " the patient then contacted the dr who placed the enteryx implant and sent him the ct films. After reviewing the ct films, the dr. Stated "maybe the metallic object was a tantalum marker to show him where to insert the needle. " he also stated "he couldn't be sure what the metal was. " the patient also sent copies of the ct films to stanford medical center. The doctor at the stanford medical center "seemed to concur with the radiologist who originally read the films that it was a surgical clip". The patient called the doctor who implanted the enteryx product and described "the horrible midriff and abdominal pressure, nausea etc, where i have a hard time leaning forward. I was having where the enteryx implant is supposed to be. " boston scientific is not aware of any medical treatment that was performed. The patient continues to suffer with "extreme abdominal pain, nausea and other symptoms. "
Patient Sequence No: 1, Text Type: D, B5
[18014816]
Other (pain with swallowing). The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date are unknown. The device remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: this product was removed from the global market in september 2005. Boston scientific corporation no longer produces the reported product. Product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02511 |
| MDR Report Key | 1324805 |
| Report Source | 04,05,07 |
| Date Received | 2009-02-25 |
| Date of Report | 2007-10-19 |
| Date Mfgr Received | 2007-10-19 |
| Date Added to Maude | 2009-02-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0040-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERYX PROCEDURE KIT |
| Generic Name | CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES |
| Product Code | LMN |
| Date Received | 2009-02-25 |
| Model Number | M00572600 |
| Catalog Number | 7260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-25 |