MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-02-16 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[67593723]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[67593724]
Information was received from a manufacturing representative about a patient with an implantable neurostimulator (ins) for obsessive compulsive disorder (ocd) and movement disorders. It was reported that the patient has an ins flipped. There were no symptoms reported.
Patient Sequence No: 1, Text Type: D, B5
[69228330]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[69228331]
Additional information was received from a manufacturing representative. The ins serial number was provided, as well as the date the flip was noticed ((b)(6) 2017) and the date the manufacturing representative became aware of the flipped ins (2017-01-23). The patient did not experience any side effects from the flipped ins. The cause of the flip remains unknown, and there was no troubleshooting performed to find it.
Patient Sequence No: 1, Text Type: D, B5
[101367573]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-00690 |
| MDR Report Key | 6335734 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-02-16 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2013-10-24 |
| Date Added to Maude | 2017-02-16 |
| 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 | LISA CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS,PR MN 007771200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007771200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2017-02-16 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-16 |