MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-05 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..
[56555424]
Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[56555425]
A subject participating in the recharge clinical trial (subject id (b)(4)) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011. On (b)(6) 2015, this subject underwent replacement of the anterior lead and rechargeable neuroregulator, with no replacement of the posterior lead at that time. On (b)(6) 2016, the site reported that the patient had a flashing red light during attempted charging. During a clinic visit on (b)(6) 2016, an error message (code 12: pulse current below minimum threshold) was encountered. This code was cleared during the visit. Later in the day on (b)(6) 2016, the subject again reported a flashing red light. On (b)(6) 2016, the subject was again seen in the clinic. Several error messages were encountered (code 12: pulse current below minimum threshold, code 25: too many therapy retries, and code 3: high impedance). This subject is not receiving therapy from the device.
Patient Sequence No: 1, Text Type: D, B5
[64746398]
A subject participating in the (b)(6) clinical trial (subject (b)(6)) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011. On (b)(6) 2015, this subject underwent replacement of the anterior lead and rechargeable neuroregulator, with no replacement of the posterior lead at that time. On (b)(6) 2016, the site reported that the patient had a flashing red light during attempted charging. During a clinic visit on (b)(6) 2016, an error message (code 12: pulse current below minimum threshold) was encountered. This code was cleared during the visit. Later in the day on (b)(6) 2016, the subject again reported a flashing red light. On (b)(6) 2016, the subject was again seen in the clinic. Several error messages were encountered (code 12: pulse current below minimum threshold, code 25: too many therapy retries, and code 3: high impedance). This subject is not receiving therapy from the device. Update: the posterior lead and rechargeable neuroregulator were replaced on (b)(6) 2016. No issues were encountered during the revision procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2016-00011 |
| MDR Report Key | 6000074 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-05 |
| Date of Report | 2017-01-11 |
| Date of Event | 2016-09-12 |
| Date Mfgr Received | 2016-12-14 |
| Device Manufacturer Date | 2011-06-23 |
| Date Added to Maude | 2016-10-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA PRITCHARD |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6517892681 |
| 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 | 2016-10-05 |
| Returned To Mfg | 2016-11-17 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | C4-07889 |
| Device Expiration Date | 2014-06-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-10-05 |