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 2017-08-25 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[83685212]
Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type lead. 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
[83685213]
A health care provider (hcp) reported via a manufacturer representative that the patient felt dizzy. The patient was implanted for obsessive compulsive disorder and they have had a few improvements of their symptoms during the day, but they felt dizzy. The patient did not feel any shocking or jolting even after the hcp palpated the system. The implantable neurostimulator (ins) was checked and impedances were measured to be quite high around 5,000 ohms. No further patient complications were anticipated. The patient's indication for use is obsessive compulsive disorder.
Patient Sequence No: 1, Text Type: D, B5
[102732603]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102732604]
Additional information received from a manufacturer representative reported the cause of the high impedances were still trying to be determined. An x-ray was done, but it did not show any failure of the extension. The patient did not experience any falls or trauma. No additional diagnostics or troubleshooting was done. The issue was not resolved.
Patient Sequence No: 1, Text Type: D, B5
[102896899]
Information references the main component of the system and other applicable components are: product id (b)(4) lot# 0208262330 implanted: (b)(4) 2014 explanted: product type lead product id (b)(4) lot# 0208262331 implanted: (b)(4) 2014: product type lead. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102896900]
Additional information received from a health care provider (hcp) via a manufacturer representative reported the cause of the patient feeling dizzy was possibly an impact from a car accident in (b)(6) 2016. The patient did not have any injuries from the car accident. X-rays were done and they were normal. The implantable neurostimulator (ins) was checked and no issues were found. Impedances were normal and the issue was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-03505 |
| MDR Report Key | 6821662 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-25 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-10-04 |
| Date Added to Maude | 2017-08-25 |
| 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 | 2017-08-25 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-08-25 |