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 2018-12-18 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[130686522]
Other relevant device(s) are: product id: 3391-40. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[130686523]
Information was received from a healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for obsessive compulsive disorder (ocd). It was reported that the patient's had two new leads implanted, but one of the leads was malpositioned. The patient's lead will be explanted and replaced. There were no symptoms reported. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[131840910]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131840912]
Additional information was received from a health care provider (hcp). It was reported that the cause of the malpositioned lead was due to a procedure related accuracy issue. The surgeon realized the issue once the surgery was over. Another intervention in planned, however there is no surgery date yet. The patient has therapy turned off in that lead in the meantime.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2018-27909 |
| MDR Report Key | 8174771 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-18 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2018-12-18 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| 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 | 2018-12-18 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-18 |