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 2016-05-19 for SYNCHROMED EL 8627L18 manufactured by Rice Creek Mfg.
[45528790]
Other applicable components are: product id: neu_unknown_cath, product type: catheter.
Patient Sequence No: 1, Text Type: N, H10
[45528791]
Information was received from consumer via a company representative regarding a patient receiving prialt dose and concentration not reported via an implantable pump. The indication for use was non-malignant pain. Per the reporter during a replacement recently the catheter broke and part of it was lodged in the patient's spinal column. The patient stated that their physician said that the prialt being released into their system was stable and safe, however the patient had to increase their use of oral narcotics and was very worried they would end up in the hospital very soon. The patient had been unhappy with their previous physician which resulted in the patient switching physicians.
Patient Sequence No: 1, Text Type: D, B5
[55332855]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55332856]
Additional information was received from a consumer. It was noted the catheter also leaked.
Patient Sequence No: 1, Text Type: D, B5
[58490304]
Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2016, product type: catheter. Corrected information: additional information received indicated the correct manufacturing site number for this event is (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[58490305]
Additional information received reported that the catheter that was implanted in the patient? S original pump broke. A dye test was done which confirmed the broken catheter and the patient had piece of the broken catheter at the bottom of their spine. Per the patient the surgery to remove the piece of catheter was too risky. The pump and catheter had to be replaced. The pump was replaced due to normal battery depletion. The patient stated they didn? T know what caused the catheter to break.
Patient Sequence No: 1, Text Type: D, B5
[58635094]
Patient Sequence No: 1, Text Type: N, H10
[58635095]
Additional information was received from a consumer stating the patient's catheter broke and the healthcare provided did not diagnose it right away, resulting in prialt being delivered into the patient's soft tissue instead of into the csf.
Patient Sequence No: 1, Text Type: D, B5
[100977056]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2016-02051 |
| MDR Report Key | 5667264 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-05-19 |
| Date of Report | 2016-10-24 |
| Date Mfgr Received | 2016-10-24 |
| Date Added to Maude | 2016-05-19 |
| 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 | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263987 |
| Manufacturer G1 | RICE CREEK MFG |
| Manufacturer Street | 7000 CENTRAL AVE NE |
| Manufacturer City | FRIDLEY MN 554321200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554321200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHROMED EL |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2016-05-19 |
| Model Number | 8627L18 |
| Catalog Number | 8627L18 |
| Device Expiration Date | 2005-03-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 554321200 US 554321200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-19 |