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 2017-04-09 for ACTIVA 3391-28 manufactured by Medtronic Neuromodulation.
[72174030]
Patient Sequence No: 1, Text Type: N, H10
[72174031]
A health care provider (hcp) reported via a manufacturer representative that there was an issue with the lead during the implant procedure. The lead was 8 mm short when checked with intraoperative imaging. The lead being 8 mm short prevented the hcp from implanting the lead for obsessive compulsive disorder (ocd). The hcp had to use another lead that was not approved for ocd. The hcp did not want to use a 40 cm long lead because they thought that 40 cm was too long. The cause of the event was unknown. The lead was replaced, but the issue was not resolved. The patient was alive with no injury. The patient's indication for use is obsessive compulsive disorder. No further patient complications were anticipated.
Patient Sequence No: 1, Text Type: D, B5
[74278673]
Patient Sequence No: 1, Text Type: N, H10
[74278674]
Additional information received from a manufacturer representative reported that there were no clinical consequences for the patient and the issue was resolved after replacing the lead. The health care provider (hcp) had verified the lead to be 8 mm short of the expected length of 28 cm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-01338 |
| MDR Report Key | 6474658 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-09 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-04-26 |
| Date Added to Maude | 2017-04-09 |
| 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 NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER |
| Product Code | MFR |
| Date Received | 2017-04-09 |
| Model Number | 3391-28 |
| Catalog Number | 3391-28 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2017-04-09 |