MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-25 for NEU_UNKNOWN_PROG manufactured by Medtronic Neuromodulation.
[39208699]
Concomitant medical products: product id: 8637-40, serial# (b)(4) implanted: (b)(6) 2013, product type: pump. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39208700]
Information received from a consumer patient with an implanted pump. Indication for use was noted as non-malignant pain and chronic low back pain. It was reported that the patient felt the manufacturer should make it easier for the physician to reach a representative when they "need to correct my pain pump when needed. " the last time the physician was told he had to call back later. Event date, drug(s) in the pump, cause of event, circumstances that led to pump correction, symptoms, interventions, and outcome were not reported. Additional information has been requested, but was not available as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2016-01017 |
| MDR Report Key | 5460234 |
| Date Received | 2016-02-25 |
| Date of Report | 2016-01-29 |
| Date Mfgr Received | 2016-01-29 |
| Date Added to Maude | 2016-02-25 |
| 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 | 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 | 0 |
| Generic Name | LEGGING, COMPRESSION, NON-INFLATABLE |
| Product Code | LLK |
| Date Received | 2016-02-25 |
| Model Number | NEU_UNKNOWN_PROG |
| Catalog Number | NEU_UNKNOWN_PROG |
| 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 | 2016-02-25 |