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 2020-03-27 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[186325553]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186325554]
Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use. It was reported motor stall occurred. The reported event date was (b)(6) 2020. A volume discrepancy occurred; the expected volume was 3. 2 ml and they withdrew 33 ml. The physician reported morphine withdrawal symptoms. A scanner was done to check the catheter and everything was okay. The physician was trying to decrease the patient's intrathecal treatment, and the patient was stabilized. It was stated with the covid-19 crisis, the withdrawal of the pump was postponed, and the date was unknown. The issue was not resolved. The patient's status was alive - no injury. There were no identified contributing factors. Further complications were not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06274 |
| MDR Report Key | 9889202 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2020-03-27 |
| 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 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHROMED II |
| Generic Name | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
| Product Code | LKK |
| Date Received | 2020-03-27 |
| Model Number | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2019-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |