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 2016-02-24 for ASCENDA 8780 manufactured by Medtronic Neuromodulation.
[38893379]
Concomitant medical products: product id: 8637-20, serial# (b)(4), implanted: (b)(6) 2015, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38893380]
Information was received from a consumer regarding a patient receiving morphine (concentration and dose unknown by the reporter) via an implanted pump. The indication for pump use was non-malignant pain and failed back surgery syndrome. On (b)(6) 2015, the patient reported that she had a pump revision on (b)(6) 2015. The patient had pain; she did not remember when the pain started. The pump was not in the right spot and had to be tacked down. Per the patient, the hcp (healthcare professional) cleaned "yellow, pussy stuff off the pump" and it was anchored. Additional information was received from the hcp on (b)(6) 2015 and it was reported that there was no "yellow pus"; it was fat cells. Per the hcp, the pump migrated the same as her breast implant and both required revision. The cause of the pump migration was not reported. Additional information received from the consumer patient. The event occurred on (b)(6) 2015. The patient was not getting pain relief and pain was at the pump site. The pump shifted down lower in buttocks and catheter had migrated out of intrathecal space. It was unknown what led to the event. The patient did describe issues with the "implants shifting, patient explained a tissue disorder. " a dye study was done to reveal displacement of catheter. The catheter was replaced and the pocket was revised on (b)(6) 2015. The manufacturer representative knew that the patient was explained about issues that occurred and that they understood what had to be done. The patient's status at time of report was noted as "alive-no injury. " the manufacturer representative was informed of the event on (b)(6) 2015. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-00981 |
| MDR Report Key | 5456987 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-02-24 |
| Date of Report | 2015-10-30 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-10-30 |
| Device Manufacturer Date | 2015-02-16 |
| Date Added to Maude | 2016-02-24 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENDA |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2016-02-24 |
| Model Number | 8780 |
| Catalog Number | 8780 |
| Device Expiration Date | 2017-02-16 |
| 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 | 2016-02-24 |