MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..
[186324519]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186324520]
Information was received from a consumer regarding a patient who was currently receiving fentanyl and bupivacaine via an implantable pump for non-malignant pain. The drug concentration and dose rates for both fentanyl and bupivacaine were unknown. It was reported that the patient was having to press on her ribs which caused discomfort when using the personal therapy manager (ptm). It was noted that the patient? S pump was originally placed too high, so she had surgery in august. Refer also to mfr report # 3004209178-2019-08476 for previous events. It was further reported that that for the past few days the patient had been coughing, throwing up, and has had a headache in the back of her head. The date (b)(6) 2020 is considered an approximate date of event (specific month and year known only). When she was throwing up and coughing, the patient felt the pump move from her bellybutton to her ribs. This happened today and the patient was now in a lot of pain. It was further noted that she hurts badly when she coughs, and the patient couldn? T move. The patient? S blood pressure was 238/192. The patient tried calling her healthcare provider but had gotten no answer and the emergency room (er) would not see her since she was a pain patient. The patient was questioning if it was ok to leave this over the weekend until she could see her healthcare provider. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[187332789]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187332790]
Additional information was received via a consumer. The patient was coughing and she thought she heard an alarm the other day, but was not hearing it now. It was noted that a healthcare provider was coming to her home to do a pump refill today, but she had not heard from them and her alarm date was tomorrow. At the time of the report it was advised to call the healthcare provider and home refill company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06414 |
| MDR Report Key | 9901688 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2016-09-13 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | 8637-20 |
| Catalog Number | 8637-20 |
| Device Expiration Date | 2018-02-28 |
| 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 | 2020-03-30 |