MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-01-05 for NEU_INS_STIMULATOR UNKNOWN manufactured by Medtronic Neuromodulation.
[16192137]
Ins model 7427, serial #(b)(4), implanted: (b)(6) 2008, explanted: unknown; extension model 748951, serial #(b)(4), implanted: (b)(6) 2003, explanted: unknown; extension model 748951, serial #(b)(4), implanted: (b)(6) 2003, explanted: unknown; lead model 3998cws, serial #(b)(4), implanted: (b)(6) 2003, explanted: unknown.
Patient Sequence No: 1, Text Type: N, H10
[16317559]
It was reported that the patient was admitted to the hospital intensive care unit twelve hours following implanting of a neurostimulator because of high potassium levels and a heart rate of 19. The potassium was reported to be fluctuating from high to low. The patient was reported to be a diabetic, have chronic obstructive pulmonary disease and other medical conditions. It was reported that the patient's potassium level needed to be brought under control prior to implanting the neurostimulator. 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 | 3007566237-2012-00031 |
| MDR Report Key | 2399577 |
| Report Source | 00 |
| Date Received | 2012-01-05 |
| Date of Report | 2011-12-15 |
| Date Mfgr Received | 2011-12-15 |
| Date Added to Maude | 2012-01-06 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55431 |
| Manufacturer Country | US |
| Manufacturer Postal | 55431 |
| Manufacturer Phone | 7635263987 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEU_INS_STIMULATOR |
| Generic Name | SURGICAL TABLE CUSHION |
| Product Code | LWG |
| Date Received | 2012-01-05 |
| Model Number | UNKNOWN |
| 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 55421120 US 55421 1200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-01-05 |