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 2020-02-09 for IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Rice Creek Mfg.
[178336505]
Bagatti, d. , messina, g. Cytotoxic lesion in the splenium of corpus callosum associated with intracranial infection after deep brain stimulation. World neurosurgery. 2019. Doi: 10. 1016/j. Wneu. 2019. 12. 114. Date of event: year is known, but month and day are not confirmed. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about additional information regarding the reported event. Implant date: month and year are known, but day is not confirmed. Section d information references the main component of the system. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, implanted: (b)(6) 2006, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178336506]
Summary: cytotoxic lesions of the corpus callosum (cloccs) are present in a wide range of clinical conditions. The term? Cloccs? Reflects current understanding of the underlying pathophysiology of these lesions and does not necessarily imply that they are confined to the splenium (scc). Since the symptoms are variable and non-specific, the clinical diagnosis can be difficult. Brain mri is of pivotal value in the investigation. We report the case of a patient suffering from obsessive-compulsive disorder (ocd) who underwent bilateral deep brain stimulation (dbs) of the nucleus accumbens (nacc) and developed infection along the surgical path of both electrodes associated with cytotoxic lesion in the scc. Reported event: a 33 year old male patient implanted with bilateral deep brain stimulation (dbs) for chronic refractory obsessive compulsive disorder (ocd) experienced cytotoxic lesions of the corpus callosum following dbs implant infection. The patient received 1 g of iv-cefazolin sodium prior to skin incision and 240 mg of iv-gentamicin postoperatively. The patient presented swelling, redness, and heat over the surgical site approximately 7-10 days after discharge post dbs implant. Neurological examination showed expressive aphasia, peripheral deficit of the right facial nerve, and moderate paresis of the right upper limb. Brain-ct showed bilateral edema with flattening of adjacent cortical sulci along the surgical path of the leads. Brain-mri demonstrated a small isolated lesion in the splenium of corpus callosum (scc) that appeared as a hypointense signal on t1- and hyperintense signal on t2-, flair-, and dwi-sequences, without enhancement after contrast administration. C-reactive protein (crp) was 11 mg/l and white cells count (wbc) was 11 ,000/mm3. Wound culture grew staphylococcus aureus and blood cultures were negative. An 8-day empiric therapy with 1000 mg/day of oral clarithromycin led to rapid improvement of the clinico-radiological picture and reduction of crp (0. 4) and wbc (7000 m3). Csf cultures were not performed. After a short hospitalization, the stable patient was discharged on oral clarithromycin for 7 days. One month follow-up mri showed nearly complete regression of the previously mentioned signal alteration. No device information could be identified in the article. See attached literature article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000030-2020-00011 |
| MDR Report Key | 9685118 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-09 |
| Date of Report | 2020-02-09 |
| Date of Event | 2006-11-01 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-09 |
| 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 | RICE CREEK MFG |
| Manufacturer Street | 7000 CENTRAL AVE NE |
| Manufacturer City | FRIDLEY MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE NEUROSTIMULATOR |
| Product Code | OLM |
| Date Received | 2020-02-09 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-02-09 |