MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-22 for ACTIVA 37601 manufactured by Medtronic Europe Sarl.
[68035523]
Information references the main component of the system, other applicable components are: product id neu_unknown_lead, implanted: (b)(6) 2005, explanted: (b)(6) 2017, product type: lead. Product id: neu_unknown_lead, explanted: (b)(6) 2017, product type lead. Product id neu_unknown_ext, explanted: (b)(6) 2017, product type extension. Product id neu_unknown_ext, explanted: (b)(6) 2017 product type extension.
Patient Sequence No: 1, Text Type: N, H10
[68035524]
Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for depression. It was reported that both of the leads and extensions were explanted and replaced for a system modification. No outcome regarding the issue was provided. There was no known impact or consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
[73951298]
It was determined that this event is a duplicate of the event contained in report number 9614453-2017-00894. To this end, all subsequent information received will be submitted under report number 9614453-2017-00894 rather than this report. 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
[98782029]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614453-2017-00895 |
| MDR Report Key | 6349887 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-22 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-04-19 |
| Device Manufacturer Date | 2016-03-14 |
| Date Added to Maude | 2017-02-22 |
| 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 WOODWARD 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 EUROPE SARL |
| Manufacturer Street | ROUTE DU MOLLIAU 31 CASE POSTALE |
| Manufacturer City | TOLOCHENAZ VAUD 1131 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 1131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2017-02-22 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2017-09-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC EUROPE SARL |
| Manufacturer Address | ROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-22 |