MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-26 for INTELLIS 97715 manufactured by Medtronic Puerto Rico Operations Co..
[115103347]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[115103348]
Information was received from a healthcare professional (hcp) regarding a patient in a clinical study with an implantable neurostimulator (ins). It was reported that the patient experienced hypertension, nausea, and vomiting post-implant procedure. The patient was admitted to the hospital for monitoring overnight. The following medications were administered: 30 mg labetalol, 5mg iv hydralazine, 1 mg iv hydromorphone, 1 mg iv haloperidol and mg po olanzapine. It was noted that the bp was in normal range, the vomiting ceased on (b)(6) 2018, and the nausea decreased later in the evening. The patient had a poor appetite for days prior to the surgery, a history of hypertension, and had been off lisinopril for 2 days prior to the procedure. The plan was for extra dose of amlodipine on 7/16 pm, then continue home dose lisinopril, prn labetalol for sbp>180, prn ondansetron if the nausea continued. It was noted that the nausea was likely related to the anesthetics and opiates, and the event was not related to the device or therapy and related to the implant procedure/surgery/anesthesia. The patient was released to go home on (b)(6) 2018 and the event resolved without sequelae. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[122556920]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123990810]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2018-02217 |
| MDR Report Key | 7722351 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-26 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-07-16 |
| Date Mfgr Received | 2018-09-26 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2018-07-26 |
| 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 | INTELLIS |
| Product Code | GZJ |
| Date Received | 2018-07-26 |
| Model Number | 97715 |
| Catalog Number | 97715 |
| Device Expiration Date | 2019-06-14 |
| 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 | 2018-07-26 |