MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-02-14 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[136132960]
Date of event: please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature. The device was used for an off label indication. Other relevant device(s) are: product id: 3389, serial/lot #: unknown. O? Ate-cadena, n. , cisneros-otero, m. , ruiz-chow,? A. , arellano-reynoso, a. , kobayashi-romero, lf. , p? Rez-esparza, r. Deep-brain stimulation in treatment-resistant obsessive-compulsive disorder: clinical and molecular neuroimaging correlation. Revista colombiana de psiquiatr? A. 2018. Doi: 10. 1016/j. Rcp. 2018. 05. 002. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[136132961]
Summary: introduction: obsessive-compulsive disorder is defined by the presence of obsessions and compulsions that cause marked anxiety or distress and has been associated with a disruption in cortico-striatothalamo-cortical circuitry. After treatment, around 50% of patients continue to experience incapacitating symptoms. Deep-brain stimulation has been shown to be an effective therapeutic alternative to regular treatment. Methods: case report. Case presentation: a (b)(6) woman with a diagnosis of treatment-resistant obsessive-compulsive disorder was treated with deep-brain stimulation of the anterior limb of the internal capsule. Molecular imaging before and after the procedure was obtained and correlated with clinical features. Conclusions: deep-brain stimulation may be a therapeutic alternative to regular care in treatment-resistant obsessive-compulsive disorder and can be correlated to functional changes in suspected anatomical structures. Reported event: a (b)(6) woman who received bilateral deep brain stimulation (dbs) of the nucleus accumbens (na) for obsessive compulsive disorder (ocd) one month post-implant experienced no response to ocd symptoms and instead, had developed distressing anxiety and depressive symptoms that elicited violent behavior towards her family members. Dbs parameters were adjusted monthly with little response and presenting with a hyper-productive speech. Due to non-response and new-onset anxious and depressive symptoms, she was admitted to the neuropsychiatry department for further evaluation. After new deliberation by the psychosurgery committee, the dbs site was changed to the anterior limb of the internal capsule, bilaterally, and parameters were modified. During the first week, this change was followed by a normalization of her speech, disappearance of depressive symptoms, and improvement in anxiety. After a month, response was observed in ocd symptomatology, with a ybocs score of 30 (25% change). She no longer presented violent behavior nor depression, and her obsessions and compulsions diminished drastically, being able to perform some of her daily chores. A new 18 fdg-pet was obtained, showing a normalization of the metabolism in the anatomical sites that showed disruption at baseline. The patient was reportedly implanted with a 3389 model lead; however, it was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-00374 |
| MDR Report Key | 8339159 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-05-28 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-02-14 |
| 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 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Product Code | MFR |
| Date Received | 2019-02-14 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2019-02-14 |