MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-04-24 for ALGOLINE 81102 manufactured by Medtronic Neuromodulation.
[106704607]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106704608]
Information was received from a healthcare provider via a clinical study on 2018-apr-19 regarding a patient receiving baclofen (dose and concentration unknown) via a temporary intrathecal catheter. The indication for use was unknown. It was reported that the temporary intrathecal catheter was placed on (b)(6) 2018, and a broken catheter was identified in fluoroscopy on (b)(6) 2018. The break prevented baclofen flow and cerebrospinal fluid (csf) collection. The break was identified on day 3 of the study and on the first day of catheter movement. It was noted that the catheter was used per protocol for baclofen administration via bolus and withdrawal of csf. No drug was being administered at the time of identification of breakage, and daily fluoroscopy was part of the study protocol. No patient symptoms/sequelae were reported, and no serious adverse events (saes) were associated with the catheter break. The catheter was removed and discarded in medical waste, and the patient was withdrawn from the study. It was noted that the event was possibly related to the implant procedure. The event did not result in any of the following: in-patient hospitalization, prolongation of existing hospitalization, emergency room visit, urgent care visit, or an unscheduled clinic or office visit. No actions were taken associated with this event and it was indicated the event resolved without sequelae. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[107607637]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107607638]
Additional information was received from a healthcare provider via a clinical study on (b)(6) 2018. It was reported that the catheter may have been damaged at implant. It was specified that the hcp pulled back on the catheter while the introducer needle was in place. It was noted that the patient was a difficult implant with the temporary catheter due to significant spinal hardware in place. The break occurred while repositioning the catheter for the study.
Patient Sequence No: 1, Text Type: D, B5
[107857636]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2018-01234 |
| MDR Report Key | 7456521 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-04-24 |
| 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 NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGOLINE |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2018-04-24 |
| Model Number | 81102 |
| Catalog Number | 81102 |
| Lot Number | 0031 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-24 |