MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for SYNCHROMED II 8637-40 manufactured by Medtronic Neuromodulation.
[185585180]
Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2020, product type: catheter. Product id: 8781, serial/lot #: (b)(4), ubd: 22-jul-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185585181]
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving gablofen 500 mcg/ml for a total dose of 100 mcg/ml via an implantable pump. It was reported that the patient was seen for a routine elective replacement indicator (eri) pump replacement, and the implanted catheter did not appear to be flowing. It was noted they were unable to aspirate using catheter access port (cap) of old pump and catheter. It was unknown what factors may have led or contributed to the issue. The old pump was removed and cut sutureless connector off to revise. It was noted that no cerebrospinal fluid (csf) was dripping. They opened the spinal incision and located the catheter. The surgeon could not remove the catheter completely. The distal end appeared to be stuck somewhere inside the patient. The surgeon cut the catheter on the pump segment and they were unable to get csf to drip. The surgeon worked gently to remove it. They decided to leave a portion still in the body instead of risk of internal hemorrhage from pulling to hard. Surgical intervention occurred where the surgeon replaced the old 8781 with an new 8780 on (b)(6) 2020. Part of the old catheter remained in patient as noted above. It was noted that the issue was resolved at time of report. The patient's status at time of report was alive-no injury. The patient's medical history was asked, but unknown. The event date was (b)(6) 2020. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2020-00323 |
| MDR Report Key | 9897177 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2013-10-28 |
| 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 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 | 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 | 2015-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-30 |