MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for SYNCHROMED II 8637-40 manufactured by Mdt Puerto Rico Operations Co.
[185044667]
Concomitant medical products: product id: 8781, lot#: unknown, implanted: (b)(6) 2013, explanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185044668]
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal compounded baclofen 1500 mcg/ml at an unknown dose. It was reported that the patient experienced intermittent withdrawal symptoms (pain and tingling feeling in legs, intensity changes). A ct scan showed the anchor was in a caudal direction, and there were no visible defects to the system. During pump replacement and anchor relocation on (b)(6) 2020 due to? Exhausted/ended battery? , while opening the pocket in the abdomen, it was discovered that the connection coating (proximal part) of the catheter was damaged, and the catheter was twisted. There was also a kink at the level of the defective coating. The abdominal part the catheter was replaced with an 8784 catheter; good liquor flow was observed. The customer discarded the damaged catheter. The issue was resolved. The patient's status was alive - no injury. It was confirmed that only the pump (abdominal) segment of the catheter was replaced with an 8784 catheter, and the spinal segment was left in place. Information regarding the patient? S weight, medical history, and other medications was unavailable. The lot number of the catheter was unknown. There were no environmental, external or patient factors might have led or contributed to the event. The pump and catheter were implanted in 2013 (no further date available).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06175 |
| MDR Report Key | 9883459 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-03-15 |
| Device Manufacturer Date | 2013-05-28 |
| 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 | MDT PUERTO RICO OPERATIONS CO |
| Manufacturer Street | RD 31 KM 24 HM 4 |
| 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 | 8637-40 |
| Catalog Number | 8637-40 |
| Device Expiration Date | 2014-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT PUERTO RICO OPERATIONS CO |
| Manufacturer Address | RD 31 KM 24 HM 4 JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |