InjuryMAE
AMPLATZER (ASO) SEPTAL OCCLUDER
Received May 26, 2017 · Event occurred Feb 8, 2011
Report MW5070082 · MDR key 6600854
Device
Generic name
Septal Occluder
Manufacturer
Isomedix Operations, Inc.Product problems
- Patient-Device Incompatibility
Patient
32 YR
- Chest Pain
- Dyspnea
- Headache
- Itching Sensation
- Memory Loss/Impairment
- Rash
- Urinary Tract Infection
- Vomiting
- Tingling
- Arthralgia
- Numbness
- Irregular Pulse
- Confusion/ Disorientation
- Alteration In Body Temperature
- Chest Pain
- Dyspnea
- Headache
- Itching Sensation
- Memory Loss/Impairment
- Rash
- Urinary Tract Infection
- Vomiting
- Tingling
- Arthralgia
- Numbness
- Irregular Pulse
- Confusion/ Disorientation
- Alteration In Body Temperature
Narrative
Description of Event or Problem
CREATED IRREGULAR HEART BEAT, PAIN IN CHEST, INCREASED MIGRAINES, NAUSEA, VOMITING, BREATHING DIFFICULTIES, LOW GRADE FEVER, NUMBNESS/TINGLING LEFT FOOT, UNUSUAL RASHES/ITCHING, THYROID, LEG AND JOINT PAIN, UTI, SKIN LESIONS, MENTAL CONFUSION, MEMORY LOSS.