MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..
[185505480]
Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 24-may-2014, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185505481]
Information was received from a consumer regarding a patient receiving fentanyl (unknown concentration at 228. 7 mcg/day) via an implantable infusion pump. It was reported that the patient recently had a ct scan completed on (b)(6) 2020 from her neck down to her hip. The patient was reading off the results of the ct scan and reported that the ct found a "catheter discontinuity of the pain pump" and "apparent discontinuity of the medication pump as prescribe with a fragment of catheter tracking of the spinal canal of l1-l5, abrupt discontinuity of the catheter, long segment of catheter tubing which has appeared inside of the spinal canal, but nothing outside of the spinal canal. " the patient stated it looked like there was a fracture "in the pump. " she had been getting a lot of pain in the area where the pump and catheter are located that started in (b)(6) 2019. The pain was intermittent, and her dosage was increased 10% at her last office visit. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[187336174]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187336175]
Additional information was received from a consumer on 2020-apr-07. It was reported that the patient's recent ct scan showed that the catheter was disconnected from the pump. Because of this, the patient had not had her pump filled and the alarm had been going off since (b)(4) 2020. The reason for the call was to page a representative to help "shut off" the pump. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06356 |
| MDR Report Key | 9897352 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2016-10-26 |
| 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 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 | 2020-03-30 |