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 2020-03-26 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..
[185078714]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185078715]
Information was received from a consumer on (b)(6) 2020 regarding a patient receiving unknown baclofen (dose and concentration unknown) via an implanted infusion pump. It was reported that the patient's pump had been empty since the first or second week in (b)(6) 2020. It was noted that the patient could not get anyone to fill the pump. The patient's insurance changed and the current healthcare provider (hcp) would not fill the pump. The patient found a new hcp that was willing to see the patient, however, the new hcp was requiring a referral from the previous hcp and the patient's family could not get anyone from the previous hcp's office to call them back about a referral. No patient symptoms were reported and no further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06199 |
| MDR Report Key | 9884511 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2017-08-04 |
| Date Added to Maude | 2020-03-26 |
| 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 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 | 2020-03-26 |
| Model Number | 8637-20 |
| Catalog Number | 8637-20 |
| Device Expiration Date | 2019-01-28 |
| 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 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |