MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-09 for MANOSCAN 3890- manufactured by Given Imaging Los Angeles Llc.
[96699151]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[96699152]
According to the reporter, an account manager called to report issue with a patient reporting esophageal paralysis two days after undergoing an esophageal manometry study. Patient stated that he did not have vocal cord paralysis before the test, but got it after the test. The patient did two tests, blood test and ct scan, but the two tests showed no proof that the esophagus manometer test was responsible for the vocal cord analysis. The history of the patient illness showed that the patient had an episode of abdominal pain requiring er visit in (b)(6). Large hiatal hernia was discovered on ct scan. The patient had this pain after dinner and it was associated with heartburn.
Patient Sequence No: 1, Text Type: D, B5
[115964739]
Device evaluation the product sample was not returned to the medtronic laboratory; however, a picture was provided by the customer for analysis. This device has been used in the treatment or diagnosis of a patient. Information provided does not indicate if the reported problem was confirmed or not. The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005344223-2018-00001 |
| MDR Report Key | 7174486 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-09 |
| Date of Report | 2018-05-02 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2018-04-02 |
| Date Added to Maude | 2018-01-09 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Street | 5860 UPLANDER WAY |
| Manufacturer City | CULVER CITY CA 90230 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90230 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANOSCAN |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-01-09 |
| Returned To Mfg | 2017-12-20 |
| Model Number | 3890- |
| Catalog Number | 3890- |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Address | 5860 UPLANDER WAY CULVER CITY CA 90230 US 90230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-09 |