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 2017-12-07 for KINETRA 7428 manufactured by Medtronic Neuromodulation.
[94195540]
Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. Chang, ch. , chen, sy. , tsai, st. , tsai, hc. Compulsive skin-picking behavior after deep brain stimulation in a patient with refractory obsessive-compulsive disorder: a case report. Medicine (baltimore). 2017;96(36):e8012. Doi: 10. 1097/md. 0000000000008012. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[94195541]
Summary: rational: the therapeutic effect of deep brain stimulation (dbs) for refractory obsessive? Compulsive disorder (ocd) has been studied, but complications after this treatment have rarely been noted. Patient concerns: a (b)(6) man with treatment-resistant ocd received bilateral ventral capsule/ventral striatum stimulation for 12 months. Diagnosis: compulsive skin-picking behavior and infection were noted following 12-month dbs treatment. Intervention: we removed the implanted right-side pulse generator. Outcomes: the local inflammation and skin-picking behavior gradually improved. The stimulator device was re-implanted 4 months later. Lessons: we suggest that patients with the oc spectrum should be evaluated for skin-picking behaviors during presurgical and postsurgical follow-up to reduce the infection and device removal rates. Reported event: 1. A (b)(6) male patient with bilateral deep brain stimulation (dbs) of the ventral capsule/ventral striatum (vc/vs) for obsessive compulsive disorder (ocd) 1 year after implant displayed signs of minor inflammation in the form of an erythematous plaque of approximately 1. 5 cm2 over the right implantable neurostimulator (ins). They noted that the patient had no fever and laboratory tests showed a normal blood count. An antibiotic ointment was prescribed to treat the infection but one month later the inflammation had progressed. The authors also described the patient as being anxious that the implanted device seemed not to be fixed in their body, and that it was movable and easily infected. The patient? S family noted they displayed impulsive skin picking behaviors around the ins pocket. At the 15-month follow-up the patient still displayed improvement in therapeutic indexes (yale-brown obsessive compulsive scale (y-bocs), hamilton depression rating scale (ham-d) and global assessment of function (gaf) scale scores of 25, 28, and 65 respectively) but the right-side ins was removed to avoid further infection. Subsequently local inflammation and the patient? S skin p icking behavior reportedly resolved and an ins was reimplanted 4 months later. At the 24-month follow-up infection had not reoccurred but there was a slight worsening of their y-bocs, ham-d and gaf scores, which were 32, 33, and 61 respectively. It was noted that the patient was implanted with 3387 leads. However, it was not possible to ascertain specific device information (serial/lot numbers) from the article or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-05098 |
| MDR Report Key | 7098761 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-08-05 |
| Date Mfgr Received | 2017-11-15 |
| Date Added to Maude | 2017-12-07 |
| 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 | KINETRA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2017-12-07 |
| Model Number | 7428 |
| Catalog Number | 7428 |
| 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. Required No Informationntervention | 2017-12-07 |