MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-03-05 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.
[19903605]
It was reported to boston scientific corporation in 2006 that an enteryx procedure kit was implanted (male patient; age and weight are unknown) to correct symptoms of gastroesophageal reflux disease (gerd) in 2004. According to the complainant, "within days of the procedure, patient had shortness of breath, along with pain to the left side of chest. It was reported to doctor on follow-up visits. Patient has also seen regular doctor who had numerous tests performed on patient, including heart monitors, angiogram and an mri of the chest. No problems were noted to explain the breathing and left chest pain, although the enteryx injected material was visible. Neither doctor had an explanation for the patient condition. The breathing makes it difficult for patient to walk up a flight of stairs. The chest pain starts from just below the rib cage and left of the midline. It travels up into the throat. " as of 2006, the patient was still experiencing swallowing problems, pain, and shortness of breath and has lost approximately 10 pounds since the procedure was performed. There hasn't been any treatment for this patient's condition, including dilatations.
Patient Sequence No: 1, Text Type: D, B5
[20096303]
The lot number is unknown; therefore, the manufacture date cannot be determined. 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. Other: product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02653 |
| MDR Report Key | 1333596 |
| Report Source | 05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2006-10-11 |
| Date of Event | 2004-04-17 |
| Date Mfgr Received | 2006-10-11 |
| Date Added to Maude | 2009-03-05 |
| 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 | 2009-03-05 |
| 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 | 2009-03-05 |