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 2018-02-01 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR 37604 manufactured by Medtronic Puerto Rico Operations Co..
[98752147]
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
[98752148]
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 (ins) for obsessive compulsive disorder (ocd). The patient contacted physicians on (b)(6) 2017 to report a four day history of severe suicidal ideation than usual baseline. It was noted a physician had adjusted the deep brain stimulation (dbs) on (b)(6) 2017 to a stimulation amplitude of 5. 3 v bilaterally and believed the suicidal ideations did not seem likely related to the device given the lack of temporal association with adjustment to stimulation and the current presentation to the patient's longitudinal history of chronic depression. There were no significant stressors or changes in psychotropic medication nor neurovegetative disturbance, and the patient had no active intent to commit suicide, but was struggling to cope. The patient was hospitalized on (b)(6) 2018 for observation and monitoring. The event outcome was considered ongoing. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[100190910]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102901784]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102901785]
Additional information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep). Interventions related to the issue include attendance of inpatient therapy programs. Diagnostics were not specified by the hospital that admitted the patient. It was noted the patient had montreal cognitive assessment (moca) and yale-brown obsessive compulsive scale (ybocs) scores of (b)(6) and (b)(6), respectively, during a study visit on (b)(6) 2018. It was also noted the patient has a history of sever treatment resistant ocd, moderate depressive disorder, mix cluster of personality traits and long-term unemployment and failed job interviews. Acute risks were described as low and the patient was discharged with no change in treatment. The patient readmitted themselves to another hospital following discharge and currently continues as an inpatient. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-00313 |
| MDR Report Key | 7233640 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-01 |
| Date of Report | 2019-01-28 |
| Date of Event | 2017-12-25 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2016-08-09 |
| Date Added to Maude | 2018-02-01 |
| 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 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 |
| Product Code | MFR |
| Date Received | 2018-02-01 |
| Model Number | 37604 |
| Catalog Number | 37604 |
| Device Expiration Date | 2018-01-28 |
| 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 MN 007771200 US 007771200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2018-02-01 |