MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-02-24 for EXOGEN 4000 OR71034100 71034100 manufactured by Smith & Nephew Orthopaedics.
[15783551]
It was reported that the patient experienced chest pain that resolved with treatment with sublingual ntg about 4 hours following the use of exogen. She did not seek emergency medical care for the chest pain. She reported the episode the following morning to her cardiologist , concerned that the chest pain was a result of an interaction between exogen and her implantable cardioverter defibrillator. He advised her to discontinue exogen. The patient had used exogen twice before without problem, however, she experienced the chest pain with her third treatment. She was prescribed exogen for the nonunion of a proximal left humerus fracture. She has a history of cardiovascular disease and is s/p coronary artery by-pass graft surgery. Because of concerns about a potential interaction, the patient was subsequently referred back to the cardiologist for a pre-op evaluation on (b)(6) 2012 for surgical treatment of the nonunion.
Patient Sequence No: 1, Text Type: D, B5
[15945408]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2012-00107 |
| MDR Report Key | 2466810 |
| Report Source | 04 |
| Date Received | 2012-02-24 |
| Date of Report | 2012-01-26 |
| Date of Event | 2012-01-26 |
| Date Mfgr Received | 2012-01-26 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2012-02-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. CONNIE MCBROOM |
| Manufacturer Street | 1450 E. BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995985 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXOGEN 4000 |
| Generic Name | BONE GROWTH STIMULATOR |
| Product Code | LPQ |
| Date Received | 2012-02-24 |
| Model Number | OR71034100 |
| Catalog Number | 71034100 |
| Lot Number | 11LM02401 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-02-24 |