MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-14 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Reshape Lifesciences.
[94818608]
This patient was implanted with the maestro rechargeable system on (b)(6) 2016. On (b)(6) 2016, the patient visited the emergency room and was treated for apparent infection with iv antibiotics. The patient was not admitted to the hospital, but was sent home the same day on oral antibiotics (bactrium). Patient was on bactrium from (b)(6) 2016 through (b)(6) 2017. At a clinic visit on (b)(6) 2017, the incision was reported to appear as if it was healing normally. No further reports have been received for this patient. This mdr covers investigation of the anterior lead. Refer to mdr 3005025697-2017-00024 for report of the rechargeable neuroregulator and mdr 3005025697-2017-00026 for report of the posterior lead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00025 |
| MDR Report Key | 7116896 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-14 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2017-02-23 |
| Device Manufacturer Date | 2015-06-08 |
| Date Added to Maude | 2017-12-14 |
| 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 | RESHAPE LIFESCIENCES |
| 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 | ANTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2017-12-14 |
| Model Number | 2200A-47E |
| Catalog Number | 2200A-47E |
| Lot Number | CR-01922 |
| Device Expiration Date | 2018-06-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE LIFESCIENCES |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-14 |