MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-23 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..
[83514062]
High impedance of the posterior lead was experienced during an initial implant procedure of the maestro rechargeable system in this patient. After confirming this was not caused by the connection of the lead to the neuroregulator, the posterior lead was replaced during the same procedure. The replacement posterior lead also resulted in high impedance so was also replaced and the procedure completed. Both posterior leads that resulted in high impedance measurements were returned for analysis. This mdr covers investigation of the first posterior lead that was replaced (serial number (b)(4)). Refer to mdr3005025697-2017-00021 for report of the second posterior lead that was replaced during the procedure (serial number (b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00020 |
| MDR Report Key | 6814585 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-07-31 |
| Date Mfgr Received | 2017-07-31 |
| Device Manufacturer Date | 2016-05-26 |
| Date Added to Maude | 2017-08-23 |
| 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 | MR. RANDY HOYT |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6517892671 |
| Manufacturer G1 | ENTEROMEDICS, INC. |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAESTRO RECHARGEABLE SYSTEM |
| Generic Name | POSTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2017-08-23 |
| Returned To Mfg | 2017-08-01 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | C4-12858 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTEROMEDICS, INC. |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-23 |