MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-30 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[187299490]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187299491]
Additional information received indicated that the catheter occlusion was a contributing factor to the difficulty aspirating the remaining volume on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
[187303701]
Product id 8731sc, lot# 0203447541, implanted: (b)(6) 2010 explanted: (b)(6) 2020. Product type catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8731sc, lot #: 0203447541 , ubd: 2012-02-11, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187303702]
Additional information was received from a foreign hcp via a clinical study. It was reported that the device diagnosis was catheter occlusion. The catheter was explanted and replaced on (b)(6) 2020, and the explanted catheter was reportedly disposed of according to biohazard instructions. The event was resolved without sequelae as of (b)(6) 2020. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[188944302]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188944323]
Additional information was received on 2020-apr-21. It was reported that the old catheter was not examined during the procedure; however, after the revision sufficient liquor [csf] could be easily collected via the side port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06394 |
| MDR Report Key | 9898511 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2016-10-18 |
| 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 | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2018-04-14 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |