MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[185776312]
Other relevant device(s) are: product id: 8780, serial#: (b)(4), product type: catheter, product id: 8780, ubd: 08-mar-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185776315]
Information was received from a healthcare provider (hcp), and from a consumer via a company representative regarding a patient receiving morphine 20mg/ml at 2. 0mg/day via an implantable pump. It was initially reported the patient was admitted on (b)(6) 2020 because they were rapidly decompensating, intubated, and sedated. The hcp was requesting a rep to interrogate the pump. An additional report was received. On (b)(6)2020 it was reported that the patient was having a mild procedure done and the doctor? Nicked? The catheter. According to the present or (operating room) staff it was not nicked, but completely cut, and they removed the spinal segment accidentally. The patient ended up in the er (emergency room) for withdrawal symptoms. The patient was discharged (b)(6) 2020 and came straight to the surgery center for a catheter revision to implant a new catheter. After the procedure the patient reported severe pain and pelvic pain. Then patient was transported to a local hospital, then to a different hospital for a possible subarachnoid hemorrhage and seizures. The environmental, external or patient factors that may have led or contributed to the issue was provided as the catheter was cut and the patient experienced withdrawal. The were no diagnostics or troubleshooting performed. The actions and interventions taken to resolve the issue was a catheter revision-reimplantation and starting the patient on 2. 0mg/ml per day instead of the previous rate of 3. 3ml/day. The issue was not resolved at the time of the report and it was noted the healthcare provider would not have any further information regarding the event. The patient status was noted as alive, with injury with the injury reported as the patient had withdrawal and went to the hospital, the patient was released on (b)(6) 2020 to have a catheter revision. Since the revision, the patient was back in the hospital, unknown as to the reason with severe pain and seizures. No further complications were reported regarding the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06461 |
| MDR Report Key | 9904516 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-31 |
| Model Number | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2019-10-14 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |