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 2020-03-25 for SYNCHROMED II 8637-40 manufactured by Mdt Puerto Rico Operations Co.
[184929171]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184929172]
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine 20 mg/ml at a dose of 11. 5 mg/day via an implantable pump. It was reported that the patient came for a regular refill procedure on (b)(6) 2020, and interrogation of the pump showed that there was an active motor stall for more than 1092 hours. It was noted that the patient did not have withdrawal symptoms or pain, and the pump had no acoustic alarm. It was also noted that the patient had an mri (magnetic resonance imaging) on (b)(6) 2020 and no telemetry was performed after the mri. The doctor filled the pump, and per interrogation the expected volume was 3. 7 ml, and the effective volume was 4. 5 ml. After the refill procedure, the pump showed in the log files that the motor stall was recovered that day ((b)(6) 2020). The session reports from the initial interrogation and after updating the pump with the logs was provided and showed the motor stall that occurred on (b)(6) 2020 due to the mri along with the motor stall recovery once the interrogation and programming performed were on (b)(6) 2020. At the time of the report the pump remained implanted and in use with no surgical intervention taken/plan ned, and the issue was resolved with a patient status of alive without injury. No complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[186453987]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2020-06140 |
| MDR Report Key | 9880261 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-24 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2013-09-12 |
| Date Added to Maude | 2020-03-25 |
| 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 | MDT PUERTO RICO OPERATIONS CO |
| Manufacturer Street | RD 31 KM 24 HM 4 |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0592-2009 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHROMED II |
| Generic Name | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
| Product Code | LKK |
| Date Received | 2020-03-25 |
| Model Number | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2015-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT PUERTO RICO OPERATIONS CO |
| Manufacturer Address | RD 31 KM 24 HM 4 JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |